Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.

Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.. 

Essential functions of the job include but are not limited to:  

• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .  
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

Qualifications: 

Minimum Required: 

• Graduate, postgraduate, 4-year college degree 
• Equivalent experience ideally in a scientific or healthcare discipline 
• Previous CRO experience
• 5+ years Oncology experience
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience. 
• Experienced leading interactions with US/European/APAC or other regions institutions
• Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

• Bachelors in law, scientific fields, business administration or equivalent degree 
• Excellent organizational and communication skills and attention to detail 
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations 
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  
• Executes time-sensitive matters while maintaining accuracy and attention to detail.  
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  
• Displays sound business judgment and a proactive, independent work style.  
• Proficient in MS Office software programs and computer applications  
• Handles sensitive issues with discretion.  
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.  
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.  

#LI-Remote

#LI-TB1

Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.

Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.. 

Essential functions of the job include but are not limited to:  

• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .  
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

Qualifications: 

Minimum Required: 

• Graduate, postgraduate, 4-year college degree 
• Equivalent experience ideally in a scientific or healthcare discipline 
• Previous CRO experience
• 5+ years Oncology experience
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience. 
• Experienced leading interactions with US/European/APAC or other regions institutions
• Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

• Bachelors in law, scientific fields, business administration or equivalent degree 
• Excellent organizational and communication skills and attention to detail 
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations 
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  
• Executes time-sensitive matters while maintaining accuracy and attention to detail.  
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  
• Displays sound business judgment and a proactive, independent work style.  
• Proficient in MS Office software programs and computer applications  
• Handles sensitive issues with discretion.  
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.  
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.  

#LI-Remote

#LI-TB1

Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.

Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.. 

Essential functions of the job include but are not limited to:  

• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .  
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

Qualifications: 

Minimum Required: 

• Graduate, postgraduate, 4-year college degree 
• Equivalent experience ideally in a scientific or healthcare discipline 
• Previous CRO experience
• 5+ years Oncology experience
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience. 
• Experienced leading interactions with US/European/APAC or other regions institutions
• Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

• Bachelors in law, scientific fields, business administration or equivalent degree 
• Excellent organizational and communication skills and attention to detail 
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations 
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  
• Executes time-sensitive matters while maintaining accuracy and attention to detail.  
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  
• Displays sound business judgment and a proactive, independent work style.  
• Proficient in MS Office software programs and computer applications  
• Handles sensitive issues with discretion.  
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.  
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.  

#LI-Remote

#LI-TB1

Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.

Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.. 

Essential functions of the job include but are not limited to:  

• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .  
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

Qualifications: 

Minimum Required: 

• Graduate, postgraduate, 4-year college degree 
• Equivalent experience ideally in a scientific or healthcare discipline 
• Previous CRO experience
• 5+ years Oncology experience
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience. 
• Experienced leading interactions with US/European/APAC or other regions institutions
• Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

• Bachelors in law, scientific fields, business administration or equivalent degree 
• Excellent organizational and communication skills and attention to detail 
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations 
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  
• Executes time-sensitive matters while maintaining accuracy and attention to detail.  
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  
• Displays sound business judgment and a proactive, independent work style.  
• Proficient in MS Office software programs and computer applications  
• Handles sensitive issues with discretion.  
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.  
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.  

Reasonable estimate of the current range for Poland: 230,200 - 287,800 PLN 

#LI-Remote

#LI-TB1

Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.

Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.. 

Essential functions of the job include but are not limited to:  

• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .  
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

Qualifications: 

Minimum Required: 

• Graduate, postgraduate, 4-year college degree 
• Equivalent experience ideally in a scientific or healthcare discipline 
• Previous CRO experience
• 5+ years Oncology experience
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience. 
• Experienced leading interactions with US/European/APAC or other regions institutions
• Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

• Bachelors in law, scientific fields, business administration or equivalent degree 
• Excellent organizational and communication skills and attention to detail 
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations 
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  
• Executes time-sensitive matters while maintaining accuracy and attention to detail.  
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  
• Displays sound business judgment and a proactive, independent work style.  
• Proficient in MS Office software programs and computer applications  
• Handles sensitive issues with discretion.  
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.  
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.  

#LI-Remote

#LI-TB1

Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.

Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.. 

Essential functions of the job include but are not limited to:  

• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .  
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

Qualifications: 

Minimum Required: 

• Graduate, postgraduate, 4-year college degree 
• Equivalent experience ideally in a scientific or healthcare discipline 
• Previous CRO experience
• 5+ years Oncology experience
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience. 
• Experienced leading interactions with US/European/APAC or other regions institutions
• Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

• Bachelors in law, scientific fields, business administration or equivalent degree 
• Excellent organizational and communication skills and attention to detail 
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations 
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  
• Executes time-sensitive matters while maintaining accuracy and attention to detail.  
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  
• Displays sound business judgment and a proactive, independent work style.  
• Proficient in MS Office software programs and computer applications  
• Handles sensitive issues with discretion.  
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.  
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.  

#LI-Remote

#LI-TB1

Precision for Medicine is growing and we are looing for a Manager, Site Contracts to join our FSP team.

Position Summary:

Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth. Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up. This role will support to negotiations of contracts when needed and to deal with key FSP clients. Will participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.

Essential functions of the job include but are not limited to: 

• Support FSP Team and Business Development Team in FSP business development initiatives.
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work.
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure.
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function.
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards.
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor.
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables .
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings
• Other tasks, as assigned.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience ideally in a scientific or healthcare discipline
• At least 6 years experience in Site Contracts departments in Clinical Research Organizations (CRO) and FSP as a service deliver model
• Experience in people management

#LI-TB1

#LI-Remote

Precision for Medicine is growing and we are looing for a Manager, Site Contracts to join our FSP team.

Position Summary:

Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth. Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up. This role will support to negotiations of contracts when needed and to deal with key FSP clients. Will participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.

Essential functions of the job include but are not limited to: 

• Support FSP Team and Business Development Team in FSP business development initiatives.
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work.
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure.
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function.
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards.
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor.
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables .
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings
• Other tasks, as assigned.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience ideally in a scientific or healthcare discipline
• At least 6 years experience in Site Contracts departments in Clinical Research Organizations (CRO) and FSP as a service deliver model
• Experience in people management

#LI-TB1

#LI-Remote

Precision for Medicine is growing and we are looing for a Manager, Site Contracts to join our FSP team.

Position Summary:

Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth. Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up. This role will support to negotiations of contracts when needed and to deal with key FSP clients. Will participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.

Essential functions of the job include but are not limited to: 

• Support FSP Team and Business Development Team in FSP business development initiatives.
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work.
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure.
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function.
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards.
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor.
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables .
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings
• Other tasks, as assigned.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience ideally in a scientific or healthcare discipline
• At least 6 years experience in Site Contracts departments in Clinical Research Organizations (CRO) and FSP as a service deliver model
• Experience in people management

#LI-TB1

#LI-Remote

Precision for Medicine is growing and we are looing for a Manager, Site Contracts to join our FSP team.

Position Summary:

Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth. Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up. This role will support to negotiations of contracts when needed and to deal with key FSP clients. Will participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.

Essential functions of the job include but are not limited to: 

• Support FSP Team and Business Development Team in FSP business development initiatives.
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work.
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure.
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function.
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards.
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor.
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables .
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings
• Other tasks, as assigned.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience ideally in a scientific or healthcare discipline
• At least 6 years experience in Site Contracts departments in Clinical Research Organizations (CRO) and FSP as a service deliver model
• Experience in people management

#LI-TB1

#LI-Remote

Precision for Medicine is growing and we are looing for a Manager, Site Contracts to join our FSP team.

Position Summary:

Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth. Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up. This role will support to negotiations of contracts when needed and to deal with key FSP clients. Will participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.

Essential functions of the job include but are not limited to: 

• Support FSP Team and Business Development Team in FSP business development initiatives.
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work.
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure.
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function.
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards.
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor.
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables .
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings
• Other tasks, as assigned.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience ideally in a scientific or healthcare discipline
• At least 6 years experience in Site Contracts departments in Clinical Research Organizations (CRO) and FSP as a service deliver model
• Experience in people management

#LI-TB1

#LI-Remote

Position Summary:

The Procurement Manager is responsible for managing an efficient and effective procurement operation for acquiring materials, supplies, equipment, and services in connection with the delivery of services supporting clinical trials. The Procurement Manager is responsible for organizing and supervising procurement activities that include but are not limited to: (i) managing and tracking the request for proposal (RFP) lifecycle; (ii) negotiating preferential pricing; (iii) establishing and tracking towards savings targets; and (iv) performing other commercial and transactional activities.

Essential functions of the job include but are not limited to:

• Developing and implementing procurement strategies that align with the company’s objectives.
• Managing the solicitation process, including reviewing/comparing specifications and costs and where appropriate supporting negotiation with vendors to reduce costs.
• Negotiating terms and conditions with suppliers to ensure the best possible prices and agreements.
• Developing tools and processes to support efficient and quality driven procurement activities.
• Maintaining an up-to-date knowledge of the industry’s market trends and developments.
• Leading transformational activities to build organizational procurement capabilities and improve procurement efficiency.
• Delivering value and competitive advantage measured by cost reduction and cost avoidance, vendor-enabled innovation, and risk mitigation.
• Ensuring compliance in purchasing process, especially in vendor selection and bidding.

Minimum Required:

• Bachelor’s degree in business administration, accounting, economics, or related field required or International equivalent education.
• Minimum of five years of work experience in life science procurement and outsourcing.

Other Required:

• Excellent communication and negotiation skills
• Proficiency in Microsoft Office Applications (Excel, Word, etc.).
• Knowledge of purchasing policies processes, and procedures.
• Knowledge and ability to negotiate best vendor terms and pricing.
• Experience with clinical trial procurement and contract research organization operations.
• Procurement and Supply Chain Certifications
• Experience managing and developing staff.

Skills:

• Strong negotiation and interpersonal skills.
• Excellent analytical, decision-making, and management skills.
• Capability to work under pressure and adapt to dynamic environments.
• Attention to detail and a commitment to achieving operational efficiency.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate. 

Position Summary:

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Position Summary:

The Associate Operational Excellence Director leverages expertise and knowledge to plan and manage initiatives and activities designed to lead teams through change management. The Associate Director develops and implements processes, standards or operational plans with the goal of operational excellence across the business collaborating across a group of diverse stakeholders. 

Essential Functions of the job include but are not limited to:

• Lead the planning, execution, and delivery of enterprise initiatives and cross-functional programs from initiation through close-out.
• Define project scope, objectives, deliverables, timelines, and success metrics in alignment with organizational priorities.
• Manage project risks, dependencies, and issues, escalating as appropriate to ensure successful outcomes.
• Apply structured project and program management methodologies to ensure consistent, predictable delivery
• Support the vision of and commitment to continuous improvement in operational excellence across all activities.
• Translate enterprise and functional strategies into actionable plans and roadmaps for enterprise initiatives.
• Support execution of transformation, process improvement, and operational effectiveness programs.
• Identify opportunities to improve efficiency, quality, scalability, and consistency across the organization.
• Ensure enterprise initiatives are aligned with governance requirements, quality standards, and regulatory expectations.
• Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation.
• Lead stakeholders in root-cause problem-solving techniques to identify core process challenges.
• Lead the development of recommendations for process improvement, leveraging subject matter experts for critical input.
• Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
• Identify, develop and execute strategies for on-going and sustained improvement in operational functions, including identification of tools, systems, staffing or other resources, procedures, and communication.
• Partner on the design and implementation of new business processes with organizational context and priorities in mind.
• Lead organizational change management to ensure adoption and sustainability of process changes.
• Lead internal communication to effectively update stakeholders on progress, performance, key issues, and blockers that may impact business attainment or critical program and project completion.
• Identify operational risks and lead implementation of mitigation plans.
• Ensure or lead the documentation of business process.
• Establish key performance metrics and dashboards for monitoring operational performance.
• Translate enterprise and functional strategies into actionable plans and roadmaps for enterprise initiatives.
• Support execution of transformation, process improvement, and operational effectiveness programs.
• Identify opportunities to improve efficiency, quality, scalability, and consistency across the organization.
• Ensure enterprise initiatives are aligned with governance requirements, quality standards, and regulatory expectations.
• Oversee or lead training and guidance to teams on new processes and how to identify improvement opportunities, building awareness on continual improvement initiatives.
• Standardizes best practices and processes across the organization to ensure consistency and sustainability.
• Monitor, measure, and analyze the effectiveness of new initiatives and processes, making adjustments as needed.
• Develop and monitor key performance indicators (KPIs) to track progress and drive decision-making.
• Monitor adoption of process, system and organizational changes to ensure long-term and sustained adoption.

Qualifications:

Minimum Required:

• Bachelor’s degree (or its international equivalent) + 12 years of related experience

Other Required:

• Experience in CRO/pharmaceutical/biotechnology drug development or demonstrated competency in the key areas of the role
• Strong drug development experience with understanding of other functions relevant to the position.

 Skills:

• Excellent written and oral communication skills
• Strong strategic and analytical thinking
• Ability to prioritize critical needs
• Strong clinical operations and drug development experience
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms 

Competencies:

• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
• Exceptional analytical and problem-solving skills. Proficiency in data analysis and performance metrics.
• Highly organized with excellent presentation, oral and written communication skills.
• Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment.
• Proven ability to effectively influence, negotiate and manage conflict.
• Strong sense of ownership and pride in quality of outputs.
• Ability to multitask tight timelines prioritizing workload and maintaining high quality standards.
• Flexible attitude with respect to work assignments, new learning opportunities, and ability to thrive in a fast-paced dynamic environment.

#LI-KH1 #LI-Remote

Position Summary: 

The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail. 

Essential functions of the job include but are not limited to: 

• Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances 
• Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
• Ability to independently formulate key messages from clinical study data 
• Ability to author complex content using knowledge/skills and understanding of processes
• Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
• Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
• Excellent problem-solving skills
• Performing literature-based research to support writing activities
• Other duties as assigned 

Qualifications: 

Minimum Required:

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise 
• 5+ years of experience as a medical writer in the sponsor and/or CRO setting 

Other Required:

• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint 
• Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development
• Impeccable attention to detail and ability to complete writing assignments in a timely manner 
• Ability to work effectively in a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments 

Preferred: 

• Advanced degree (MS/PhD)
• Oncology and/or rare disease experience (especially protocol and CSR development) 

Precision is required by law in some states, cities and or countries to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Salary Range: $101,800 - 152,600

Position Summary:

The Business Development Director - Lab Services is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree and 5 years of related sales experience; or
• Master’s Degree and 2 years of related sales experience; or
• PhD and 0-1 years of related sales experience

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven track record of successful client relationship management and business development in pharmaceutical, biotech or CRO organization with success in sales of biobanking, sample preparation services, and specialty lab services
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays

Preferred:

• Academic concentration in life sciences or related field
• Masters or Ph.D. in Life Sciences, Molecular Biology or Biochemistry
• 10 years of related sales experience

***Compensation range listed considers base salary with the potential for incentives***

#LI-KH1 #LI-Remote

Position Summary:

The Business Development Director - Lab Services is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree and 5 years of related sales experience; or
• Master’s Degree and 2 years of related sales experience; or
• PhD and 0-1 years of related sales experience

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven track record of successful client relationship management and business development in pharmaceutical, biotech or CRO organization with success in sales of biobanking, sample preparation services, and specialty lab services
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays

Preferred:

• Academic concentration in life sciences or related field
• Masters or Ph.D. in Life Sciences, Molecular Biology or Biochemistry
• 10 years of related sales experience

***Compensation range listed considers base salary with the potential for incentives***

#LI-KH1 #LI-Remote

Position Summary:

The Business Development Director - Lab Services is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree and 5 years of related sales experience; or
• Master’s Degree and 2 years of related sales experience; or
• PhD and 0-1 years of related sales experience

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven track record of successful client relationship management and business development in pharmaceutical, biotech or CRO organization with success in sales of biobanking, sample preparation services, and specialty lab services
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays

Preferred:

• Academic concentration in life sciences or related field
• Masters or Ph.D. in Life Sciences, Molecular Biology or Biochemistry
• 10 years of related sales experience

***Compensation range listed considers base salary with the potential for incentives***

#LI-KH1 #LI-Remote

Precision for Medicine, Oncology and Rare Disease is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. We are now recruiting Clinical Research Associate II to join our team in Poland.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two studies setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.

About you:

• You are calm, thoughtful, and responsive when things don’t go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Qualifications:

Minimum Required:

• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
• 2,5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research.

Other Required:

• Excellent communication and organizational skills are essential. A team player.
• Evidence of a client focused approach.
• Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
• Fluency in English and for non-English speaking countries the local language of country where position based

Preferred:

• Experience with oncology studies will be a plus
• Study start up activities experience

Please, apply in English.

Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision is required by law in some states, cities or countries to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable Estimate Of The Current Range For Poland

173,000 PLN to 259,400 PLN gross per annum

Please, apply in English.

#LI-EK1 #LI-Remote

Position Summary: 

The Senior Contract Manager plays a critical role in our ability to achieve our goals by creating, managing and maintaining strong relationships with business teams and establishing client and vendor contracts for those business teams. In this role, they will be responsible for contract negotiation, closeout, extension and renewal, and will communicate contractual changes and their context for the particular business to all stakeholders. 

Essential functions of the job include but are not limited to: 

• Reviewing, drafting and negotiating all the commercial agreements between the business and their clients and vendors, including master services agreements, consulting agreements, independent contractor agreements, confidentiality agreements, work orders, change orders and other client or vendor contracts, and escalating complex issues to the corporate legal team. 

• Ensuring adherence to company policies, procedures and contracting standards. 

• Ensuring that the relevant leadership and business teams are apprised of the status of contract negotiations and execution. 

• Coordinating execution of agreements and keeping track of expirations and other obligations. 

• Assisting in the design and maintenance of contract files and databases. 

• Assisting in designing and implementing policies and procedures to affect the timely execution of contracts. 

• Recognizing where processes can be improved and taking initiative to improve them. 

• Other tasks, as assigned. 

Qualifications: Minimum Required: 

• Post Secondary Degree or Certificate 

• Minimum of 5 years relevant experience drafting, reviewing and negotiating commercial contracts, preferably in the life science or pharmaceutical industry 

 Other Required: 

• Strong organizational skills and the ability to multi-task and prioritize in a fast-paced environment, working on time-sensitive matters while maintaining accuracy and attention to detail  

• Well-developed interpersonal skills  

• Good judgment and a proactive and independent work style  

• Proven ability to meet deadlines on multiple projects  

• Ability to work cross-functionally with various team members at different levels of the organization  

• Strong working knowledge of Microsoft Office programs (Word, Excel, Outlook)  

• Must be able to read, write, speak fluently and comprehend the English language 

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Argentina!

As a Senior CRA you'll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Communicates effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
• Assists the team managers in the preparation and review of protocols and other study documentation
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Assists with review of clinical study reports
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors
• Interacts with client, participates in proposal activities, including development and client presentations
• Initiates payment requests for investigators
• Travels as necessary according to project needs
• Other job duties as assigned 

Minimum Education & Experience: 

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Select opportunities require Oncology experience preferably in early phases
• Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary:

The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. The essential functions below will describe the PM acting in a primary / lead PM role on a study. When in a supportive role on a global study, the essential functions will be delegated by the Global Lead.

Essential functions of the job include but are not limited to:
• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Lead both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required
• Perform other duties as assigned by management
• Remain compliant with organisational training, time-reporting and any other administrative duties as required
• Provides on-going feedback for functional team members including annual performance reviews
• Ability to travel domestically and internationally including overnight stays

Qualifications:
Minimum Required:
• Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 4-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project
• Experience managing regional trials (moderate complexity) and/or supportive role in managing complex global trials

Other Required:
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project,eTMF, EDC and CTMS
• Good communication and interpersonal skills to effectively interface with others in a team setting
• Good organizational skills, attention to detail, and a customer service demeanor

• Mandarin Speaking as this is required to cover East Asia market

Competencies:
• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
• Working knowledge of project management techniques and tools
• Experience working in a cross-functional project management environment
• Fundamental understanding of cross-functional management
• Fundamental understanding of project planning, risk management and change management with an awareness of appropriate escalation
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a study team
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Good time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Good presentation, verbal and written communications skills
• Fundamental understanding of project management software
• Experience in pharmaceutical and/or device research required

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Position Summary:

The Senior Finance Analyst – Clinical Solutions Portfolio is a strategic, business-partnering role responsible for portfolio-level financial analysis across Clinical Solutions departments. The primary focus is project and portfolio financial health, including forecasting, budget performance, and financial controls, with an expanding remit into trial operations KPIs and measures as they relate to budget integrity, scope control, and delivery efficiency. 

This role requires a strong background in Project Finance within a CRO environment, excellent analytical and presentation skills, and the ability to engage credibly with department heads and senior operational leaders.

Main Duties & Responsibilities:

• Own and deliver portfolio-level financial analysis for Clinical Solutions departments, including budget health, forecast accuracy, margin performance, and risk identification. 
• Lead project financial oversight across the full project lifecycle, from award through closeout, ensuring adherence to financial best practices and internal controls. 
• Perform variance analysis (actuals vs. forecast vs. budget) to identify drivers of change, scope creep, and emerging risks. 
• Partner with project finance teams to ensure consistency and integrity of project-level data feeding portfolio reporting. 
• Support and enhance departmental forecasting and planning processes using clear, supportable assumptions. 
• Monitor budget consumption, earned value indicators, and change order impacts across portfolios. 
• Provide forward-looking insights to support proactive financial decision-making by operational leadership. 
• Contribute to the continuous improvement of financial processes, controls, and reporting standards. 
• Develop and maintain trial operations KPIs and measures that link operational performance to financial outcomes (e.g., enrollment pace vs. burn, milestone progress vs. revenue, site activity vs. cost). 
• Leverage Excel and Power BI to create scalable dashboards and analyses that support portfolio governance and executive review. 
• Translate complex financial and operational data into clear, actionable insights for non-finance stakeholders. 
• Act as a trusted finance partner to Clinical Solutions department heads, supporting planning, performance reviews, and strategic initiatives. 
• Prepare and deliver high-quality presentations and executive-ready materials summarizing portfolio performance, risks, and recommendations. 
• Support ad hoc analyses and special projects requested by Finance leadership, Clinical Operations leadership, or executive management. 
• Collaborate closely with Project Management, Clinical Operations, Data Management, and Finance teams to ensure alignment between operational execution and financial reporting. 

Minimum Education & Experience: 

• Bachelor’s degree (or its international equivalent) + 5 years of related experience.

Preferred Education & Experience (optional):

• Bachelor’s degree in finance, Accounting, Business, or a related field (or its international equivalent).
• Approximately 5-8 years of relevant experience in project finance, FP&A, or operational finance, with a strong preference for CRO or clinical research industry experience.
• Demonstrated experience managing or analysing clinical trial portfolios and complex project financials.
• Advanced Microsoft Excel skills (financial modelling, scenario analysis, large data sets).
• Working knowledge of Power BI or similar BI/visualization tools.
• Strong presentation and communication skills, with experience presenting to senior leaders and department heads.
• Solid understanding of clinical trial financial drivers, project lifecycles, and contract/budget mechanics. 

Knowledge, Skills & Competencies:

• Strong financial and analytical acumen with the ability to connect operational activity to financial outcomes.
• Executive presence and confidence interacting with senior operational leaders.
• Ability to synthesize complex data into clear narratives and recommendations.
• High attention to detail balanced with a portfolio-level, strategic mindset.
• Self-motivated, adaptable, and comfortable operating in a fast-paced, matrixed environment. 

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow, we are seeking a Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

The Proposal and Budgeting Systems Manager will be responsible for supporting the Associate Director, Proposal and Budgeting Systems with the build and maintenance of the financial and other tools used within Business Operations in support of the budget development and other Business Operations related processes and reporting needs for our internal and external clients as well as other duties as determined by his/her supervisor in accordance with all departmental processes and timelines.

Responsibilities:  

• Support the development and maintenance of financial and other related tools to be used by the Business Operations Department.
• Work with all the departments in Precision for Medicine (and sister companies as necessary) that are either budgeted for or participate in the knowledge of the services Precision provides.
• Participate in discussions with internal personnel to analyze and develop the departmental algorithms to appropriately capture budgetary needs.
• Complete assigned tasks with promptness and accuracy.
• Ensure trackers are kept up to date with status of assigned tasks.
• Participate in the implementation of rates to be used for all resources across all departments
• Work with our financial department and outside consultants to ensure the Business Operations tools and/or systems contain the necessary data for all reporting and functional requirements.
• Assist in the training of Business Operations personnel on using the tools and/or systems.
• Assist in the training of operations staff on reading and interpreting the tools and/or systems.
• Support the management of the tool(s) and/or system(s) to ensure compatibility with Precision ERP and Salesforce (and other) needs. Working directly with these vendors to ensure their tools and/or systems and our tools and/or systems are working together to provide the reporting functions needed.
• Assist Business Operations on unique client requests where systems may need to be adjusted.
• May participate in departmental initiatives.
• And other job duties as assigned by the line manager.

Minimum Education & Experience:

• Bachelor’s degree (or its international equivalent) + 5 years of related exp. Preferred Education & Experience (optional):
• 5+ years’ experience of budgeting tools and systems development
• Advanced proficiency in Microsoft Excel, including complex formulas, data modelling, and pivot tables
• Working experience with Excel VBA for automation, tool enhancement, or workflow optimization Demonstrated experience developing analytical tools or systems supporting clinical research, CRO, pharmaceutical, or healthcare-related environments or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

Skills and competencies: 

• Strong knowledge of budgeting, cost modelling and model development and analysis
• Microsoft Office Product Suite
• Additional customer related management tools as determined by the Business Operations teams
• Provide efficient quality control, recognizing problems, constructively identifying and articulating solutions Excellent interpersonal, written, and verbal communications skills
• Excellent organizational and time management skills with the ability to prioritize coordinate workload, keeping others informed of progress, timelines and any issues to meet established deadlines.
• Detailed oriented, with high focus on quality
• Demonstrated problem-solving skills.
• Sound judgment/decision-making skills
• Proficiency in Excel, Word and other Microsoft applications
• Able to work in a collaborative team environment to support departmental/company goals and values.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist based in Hong Kong.

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare. review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management.

Requirement:
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
Preferred:
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.

• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Position Summary:
The primary purpose of this position is to manage and optimize the organization’s resources and deliver resource management support to the business. On a day-to-day basis, the Resource Manager II is responsible for executing all staffing processes and activities further defined below.

Essential functions of the job include but are not limited to:
• Perform allocation and assignment of global resources for multiple departments
• Work with stakeholders to understand resource requirements
• Identify and recommends strategies to meet current and future needs
• Identifies capacity constraints and hiring needs for department leaders
• Negotiates and resolves staffing conflicts in collaboration with stakeholders
• Prepare metrics and summary reports on resourcing activities as necessary
• Recommends and influences business operations as it relates to Resource Management 
• Escalate sensitive or high-risk staffing situations to Resource Management leadership and Executive Team as necessary
• Other duties as assigned

Qualifications:
Minimum Required:

• Bachelors degree, or equivalent combination of education and experience
• 3 years resource management experience or equivalent, relevant experience and/or demonstrated competencies

Other Required:
• Proven experience in negotiating with and influencing stakeholders
• Excellent command of spoken and written English
• Demonstrated prior CRO or similar industry experience
• Demonstrated prior Resource Management experience
• Demonstrated ability to work independently and within a team environment 

Competencies:
• Strong interpersonal skills including clear and concise verbal and written communication
• Strong attention to detail
• Ability to solve complex problems using knowledge/skills, precedents and practices
• Ability to exercise independent judgment within broadly defined practices in selecting approaches and methods for obtaining results
• Ability to multi-task and prioritize in a fast-paced environment
• Appropriate financial acumen and understanding of budgets, forecasting, utilization and realization concepts

Position Summary:

The Director, Business Development (Biospecimen Solutions) is responsible for identifying, engaging, developing, and closing significant business opportunities for Precision Biospecimen Solutions in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for Biospecimen products and services, with an emphasis on biofluids, prospective collections, tissues, cells and other specialty- and central-lab service offerings
• Builds and maintains relationship and organization map for assigned and identified new Key Clients
• Retain and grow existing account base through the identification of new opportunities and exploring potential cross selling across the Precision Translational Sciences portfolio
• Follow up on all marketing leads and website inquiries to qualify leads
• Prospects for new clients, as appropriate, within the given geographic market to ensure a robust pipeline of opportunities
• Identify potential clients and decision makers within the client organization, perform needs analysis, identify opportunity, and follow up with potential customers
• Ensure that any client complaints are forwarded to the appropriate individual(s) and ultimately resolved in a prompt and professional manner
• Closes new business and expands existing business relationships
• Connects SME’s and other BD’s where added value to client is available
• Establishes a strong working relationship with marketing, clinical operations, lab operations, project management, and other internal stakeholders
• Qualifies & enriches in-bound leads
• Closes business and organically develops future – recurring business
• Attend conferences, trade shows and meetings as required
• Maintain clean customer relationship management metrics in Salesforce.com and other CRM systems
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree in Life Sciences or related field
• 1-2 years of sales experience in Life Science or Healthcare industry OR
• 3+years of Laboratory Research, Service, Clinical Operations, or customer support in Life Science industry

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven command of basic Life Science terminology and application.
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel within territory up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Academic concentration in life sciences or related field
• 5 years of related Life Sciences experience

#LI-KH1 #LI-Remote

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a CRA II (Based in Shanghai/Beijing)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology trial experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is hiring an experienced Start Up Lead based in Turkey to join our team.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions  by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• Experience in start up from either a CRO or pharmaceutical/biotech industry.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

Preferred:
• Advanced degree in life sciences or related field

Competencies:
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

#LI-NC1 #LI-Remote

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

#LI-OS1 #LI-Remote

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare, review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international 
and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.
• Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.
• May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.
• May interact with clients during KOMs, including slide development and client presentation,as required.

Qualifications:
Minimum Required:
• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and Turkish.
• Ability to prioritize workload to meet deadlines.
• Experience in driving cross-functional activities, coordination and oversight of a team.

Preferred:
• Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial.
• Must have experience using milestone tracking tools/systems.
• Must be able to assist junior SU specialists in problem resolution.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent communication, presentation, interpersonal skills, both written and spoken, 
with an ability to inform, influence, convince, and persuade.
• Flexible attitude with respect to work assignments and new learning.
• Occasional travel may be required

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two studies setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.

Precision for Medicine is recruiting Clinical Research Associate I/ Clinical Research Associate II to join our team in Turkey.

This position can be offered fully home based.

About you:

• You are calm, thoughtful, and responsive when things don’t go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Qualifications: 

Minimum Required: 

• University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional. 
• At least 6 months of experience as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management experience or equivalent experience in clinical research
• Oncology monitoring experience.

Other Required: 

• Excellent communication and organizational skills are essential. A team player
• Evidence of a client focused approach
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Fluency in English and Turkish

Preferred: 

• Start up activities experience.

Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Please, apply in English. 

#LI-EK1 #LI-Remote

Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology. Are you passionate about impacting the health and lives of patients around the world? Do you take a consultative approach to trial management, proving to be a valuable partner in trial operational delivery?

Precision for Medicine are looking to hire a (Senior) Project Manager ideally with experience in Oncology who have managed full service clinical trials within a CRO setting to join our global team.

In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology (or Rare Diseases or CNS).  Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.

Involved in all study stages, including proposal strategy, development, costing, and bid defence, and seeing studies through the full cycle to completion, managing the client relationship, project team and budget and timelines throughout.

You will work in a cross-functional team with both internal and external stakeholders, driving quality and coordinating the study team.

We offer an amazing high-energy, dedicated, collaborative team members who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and seek positive teamwork to deliver extraordinary work, we have an opportunity for you.

How we will keep you busy and support your growth:

• You will independently lead clinical projects in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. You may be called upon to run international trials as well.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

Requirements:

• Degree or similar related life science qualification, or equivalent combination of education and experience.
• Previous experience in a full service/global Project Management role working in the CRO industry is essential.
• 5 to 7 years industry experience and at least 4 years full service Project Management experience in a clinical trial setting working for a Clinical Research Organisation.
• Experience managing studies within Oncology 
• Working understanding of GCP/ICH guidelines and the clinical development process
• Ability to drive and availability for domestic and international travel including overnight stays
• Be able to communicate effectively in the English language both written and spoken
• Strong presentation skills
• Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
• Proven ability to develop positive working relationships with individual and teams internally and externally
• Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan

Precision for Medicine's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

We are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development. 

We invite you to learn more about our growing organization serving our clients that are researching ground-breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day.

Precision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two studies setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.

Precision for Medicine is recruiting Senior Clinical Research Associate to join our team in Turkey.

This position can be offered fully home based.

About you:

• You are calm, thoughtful, and responsive when things don’t go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Senior CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

Qualifications: 

Minimum Required: 

• University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional. 
• 3.5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Significant site management experience or equivalent experience in clinical research
• Oncology monitoring experience 

Other Required: 

• Excellent communication and organizational skills are essential. A team player
• Evidence of a client focused approach
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Fluency in English and Turkish

Preferred: 

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and HER records
• Experience in bioharma or relevant therapeutic area
• Start up experience

Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Please, apply in English. 

#LI-EK1 #LI-Remote

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an CRA II (based in Shanghai and Beijing or Taiwan)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for a Contracts Manager to help support our expansion across the region and around the globe!

As a leader in the Contracts organization you will review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.

Essential functions of the job include but are not limited to:

• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Other tasks as assigned.

Qualifications:

Minimum Required:

• Graduate, postgraduate, 4-year college degree
• Equivalent experience ideally in a scientific or healthcare discipline
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, vendor contracts and site Budget negotiations, but no less than 5 years’ experience.
• Experienced leading interactions with Study Teams and Sponsor

Preferred:

• Bachelors in law, scientific fields, business administration or equivalent degree
• Excellent organizational and communication skills and attention to detail
• Knowledgeable on setting up Contracting Plans - Guides for CTA & Budget negotiations
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines

Skills:

Competencies

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Displays sound business judgment and a proactive, independent work style.
• Proficient in MS Office software programs and computer applications
• Handles sensitive issues with discretion.
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.

#LI-AG2 #LI-REMOTE

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.  

Essential functions of the job include but are not limited to:   

• Serve as primary point-of-contact and primary escalation point to the client    
• Coordinate and oversees all functional services including external vendors to the established timeline and budget  
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. 
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities  
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. 
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality 
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.  
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation 
• Establish tracking metrics to monitor trial and team progress towards project goals  
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise  
• Leads both internal and client meetings and set expectations for the project team  
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues 
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency 
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project  
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required 
• Perform other duties as assigned by management  
• Remain compliant with organizational training, time-reporting and any other administrative duties as required 
• Provides on-going feedback, for functional team members including annual performance reviews  

Qualifications:  

Minimum Required:  

• North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred 
• EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred 
• Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience  
• Experience in managing complex and global trials 
• Ability to travel domestically and internationally including overnight stays  

Other Required:  

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS  
• Proven communication and interpersonal skills to effectively interface with others in a team setting  
• Proven organizational skills, attention to detail, and a customer service demeanor  

Competencies:  

• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items 
• Direct work experience in a global, cross-functional project management environment 
• Good understanding of cross-functional management  
• Good understanding of project planning, risk management and change management with an awareness of appropriate escalation 
• Proven experience in strategic planning, risk management and change management  
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective  
• Ability to lead and inspire excellence within a study team  
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency  
• Results oriented, accountable, motivated and flexible  
• Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills  
• Proven presentation, verbal and written communications skills  
• Good understanding of project management software   
• In depth proven experience in pharmaceutical and/or device research required  
• Preferred: experience with oncology & cell and/or gene therapy

#LI-KH1 #LI-Remote

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 3500 dedicated professionals and offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.

We are seeking an accomplished Senior Marketing Manager to drive strategic marketing initiatives that support our expanding Autoimmune therapeutic area business (both full-service outsourcing [FSO] and Functional Service Provider [FSP] models), and our core CRO portfolio. This role requires a highly autonomous leader with strong cross‑functional collaboration skills and the ability to translate global strategy into high‑impact execution.

In this position, you will shape and refine service messaging, design and deliver integrated marketing campaigns, generate qualified leads, and empower a growing sales team in achieving their targets. You will work closely with sales and operational stakeholders to elevate market awareness, strengthen our value proposition, and accelerate lead generation across key service lines.

• Service Marketing & Content Development
  • Lead and own strategic planning of marketing efforts for assigned areas, specifically all therapeutic marketing for our growing Autoimmune therapeutic area, clinical FSP, and related services. Support other services within our CRO offerings as assigned
  • Create messaging frameworks relating Feature/Advantage/Benefit (FAB) with proof points to optimize market positioning
  • Work with stakeholders (and agencies as needed) to create compelling, differentiated messaging based on the FAB analysis to drive product awareness and engagement with clients
  • Develop content strategies to leverage the messaging, considering omnichannel approaches
  • Drive the development, implementation, and optimization of sales enablement tools to activate the sales force in attainment of financial targets
  • Identify Autoimmune and FSP client profiles in cooperation with Lead Generation and Inside Sales Team

• Digital Marketing & Social Media
  • Develop and execute a digital content strategy, leveraging an omni-channel approach including blogs, website, SEM, SEO, AI search, social media, and other channels.
  • Ensure consistent messaging and engagement with key stakeholders across digital platforms.
  • Monitor impact of digital strategy to prioritize highest ROI activities
    
    
• Thought Leadership & Stakeholder Engagement

• Collaborate with operational, medical/scientific and commercial teams to identify relevant topics and ensure high-quality content delivery.
• Incorporate a thought leadership strategy demonstrating Precision’s focused approach to autoimmune, oncology, rare indications, and other areas identified by commercial strategy, using video, white papers, and other channels to maximize exposure
• Proactively, work with stakeholders across Precision businesses to foster convergence and holistic storytelling

• Event Management
  • Lead cross-functional planning and execution of a yearly conference strategy for assigned areas including budgeting, messaging, and execution in partnership with the PFM event team.
  • Attend select events in person

• Leadership & Strategic Contribution
  • Provide expertise and guidance to team members and cross-functional partners.
  • Lead and manage complex projects or functional areas, ensuring alignment with business goals.
  • Actively contribute to the development of departmental strategies and marketing plans.
  • Continuously improve technical skills and stay current with emerging technologies and marketing trends.
  • Ensure projects are delivered on time and within budget across the entire project lifecycle.
  • Provide competitive intelligence input to drive growth strategies.
  • Mentor junior team members and contribute to talent development across the marketing function
  • Serve as a strategic advisor to senior leadership on marketing initiatives and business impact
  •  
• Reporting:
  • Monthly reporting on all activities relevant to assigned business areas, conference planning and updates, podcasts, webinars and other key activities. 
  • Deliver actionable insights and strategic recommendations based on performance metrics, market trends, and stakeholder feedback

Minimum Education & Experience:

• Bachelor’s degree in a related field and a minimum of 12 years of relevant work experience in Marketing, Communications, Life Sciences, biotech, or healthcare sectors; advanced degree plus a minimum of 4 years of relevant work experience a plus.
• 6–8 years of experience in a marketing role with a proven track record of independently leading projects, including customer-facing initiatives.
• Demonstrated experience in therapeutic area marketing and FSP services; specific experience in Autoimmune and familiarity with broader clinical CRO services is a strong plus. Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
• Proven success in developing webinars and live events, including speaker coordination and promotional strategy.
• Exceptional analytical and problem-solving skills, with the ability to communicate complex information clearly and effectively.
• Proficiency in project management tools and methodologies, including scheduling, budgeting, and status reporting.
• Strong leadership and organizational skills, with a track record of effective stakeholder engagement.
• Ability to identify and present data-driven insights that influence strategic decision-making.
• Skilled in building and maintaining strong customer relationships through active listening and thoughtful inquiry.
• Solid understanding of end-to-end work processes, with the ability to assess and optimize for efficiency and effectiveness.
• Follows Company's Principle and code of ethics on a day-to-day basis.
• Shows appreciation for individual talents, differences, and abilities of fellow team members.
• Listens and responds with appropriate actions.
• Leads change initiatives and continuous process improvements.

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Start Up Lead (SUL) in Mexico!

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:

• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

Preferred:

• Advanced degree in life sciences or related field

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for a Contracts & Budgets Associate to help support our expansion across the region and around the globe!

The Contracts & Budgets Associate, Site Contract Management, develops and negotiates regional study budgets based on the requirements of a study protocol, as well as reviewing, drafting, negotiating and tracking a variety of legal agreements which include confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. The postholder works closely with the Clinical Operations study team and playing a key role in ensuring deliverables are in alignment with defined study timelines.

Essential functions of the job include but are not limited to:
• Develop, negotiate global study budgets based on the requirements of a study protocol.
• Review, draft and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Coordinate execution of agreements
• Support the maintenance of contract files and databases, including contract archiving.
• Recognize where processes can be improved and take corrective action.
• Other tasks, as assigned.

Qualifications:

Minimum Required:
• Bachelors degree, or equivalent level of contract management experience preferably in a clinical research or similar industry setting

Other Required:
• 1 year of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process.
• Excellent organizational and communication skills and attention to detail.

Preferred:
• Post-graduate qualification

Skills & Competencies:
• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan with some supervision as well as in a global team environment.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Displays sound business judgment and a proactive, independent work style.
• Handles sensitive issues with discretion.
• Works well independently and cooperatively with others to achieve common goals in a virtual environment 
• Is proficient in MS Office software programs and computer applications.
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.

#LI-AG2 #LI-REMOTE

Due to our continued growth, Precision for Medicine is looking for a Senior Feasibility Associate/Feasibility Manager to join our European team. This position can be covered fully remotely in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

The Senior Feasibility Associate/Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, this role has responsibility to support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate/Feasibility Manager supports pre-award feasibility projects and support business development and operational strategy teams by conducting feasibility analysis. The Senior Feasibility Associate/Feasibility Manager supports stand-alone feasibility projects and site identification and is providing feasibility support for newly awarded and/or ongoing projects. In addition, Senior Feasibility Associate/Feasibility Manager may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

Support pre-award feasibility projects

• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.

Provide support to post-award feasibility projects

• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)

Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level) Preferred:
• Postgraduate degree preferred.

Skills

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms Competencies
• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail with ability to see the big picture
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

#LI-TB1

#LI-Remote

Due to our continued growth, Precision for Medicine is looking for a Senior Feasibility Associate/Feasibility Manager to join our European team. This position can be covered fully remotely in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

The Senior Feasibility Associate/Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, this role has responsibility to support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate/Feasibility Manager supports pre-award feasibility projects and support business development and operational strategy teams by conducting feasibility analysis. The Senior Feasibility Associate/Feasibility Manager supports stand-alone feasibility projects and site identification and is providing feasibility support for newly awarded and/or ongoing projects. In addition, Senior Feasibility Associate/Feasibility Manager may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

Support pre-award feasibility projects

• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.

Provide support to post-award feasibility projects

• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)

Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level) Preferred:
• Postgraduate degree preferred.

Skills

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms Competencies
• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail with ability to see the big picture
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

#LI-TB1

#LI-Remote