Clinical Trial Jobs in Spain.
All active Clinical Trial roles based in Spain.
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Senior Site Contracts Manager - FSP
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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
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
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
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Regulatory and Start Up Specialist
Share this job
Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which 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.
Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. For this role its key for candidates to have contracts and budgeting negotiation experience for Spain.
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.
Other Required:
- Desirable to have experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- 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.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Regulatory and Start Up Specialist
Share this job
Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which 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.
Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. For this role its key for candidates to have contracts and budgeting negotiation experience for Spain.
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.
Other Required:
- Desirable to have experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- 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.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Feasibility Associate / Feasibility Manager
Share this job
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
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Feasibility Associate / Feasibility Manager
Share this job
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
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Site Contracts Manager
Share this job
Precision for Medicine is looking for a Site Contracts Manager to join our European Team. The position can be covered fully remotely from the Poland, Slovakia, Spain, Serbia, Romania or Hungary.
Position Summary:
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
- Experience in a CRO/healthcare field
- 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 and 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-TB1
#LI-Remote
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Site Contracts Manager
Share this job
Precision for Medicine is looking for a Site Contracts Manager to join our European Team. The position can be covered fully remotely from the Poland, Slovakia, Spain, Serbia, Romania or Hungary.
Position Summary:
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
- Experience in a CRO/healthcare field
- 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 and 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-TB1
#LI-Remote
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Manager, Clinical Trial Management
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Precision for Medicine is growing! We are looking for an experienced Senior Manager, Clinical Trial Management to cover the line management of our Clinical Trial Managers. The position can be covered fully remotely from Spain.
Position Summary:
- The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
- This position requires the ability to independently lead, manage, and motivate a team of CTMs and Managers (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
Essential functions of the job include but are not limited to:
- Lead, mentor, coach, and manage CTMs/PCTMs/MCTMs to support skill development, performance, and career growth in line with Precision for Medicine quality standards.
- Provide leadership and oversight across clinical programs, including clinical trial oversight where applicable.
- Partner with Clinical Operations leadership and cross-functional teams to improve CTM processes, quality, consistency, efficiency, and KPI achievement.
- Collaborate with Resourcing to ensure appropriate staffing and resource allocation.
- Set strategic action plans and provide ongoing performance feedback, technical guidance, and developmental support to direct reports.Ensure CTMs have appropriate training, tools, systems access, and resources to meet role expectations.
- Identify quality risks, recommend corrective actions, and escalate issues as needed to leadership, PMs, and DPMs.Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.
- Develop and update Clinical Operations SOPs, templates, and work instructions; contribute to clinical documentation as needed.
- Support CTM hiring, onboarding, and training in collaboration with HR and Learning & Development.
- Promote Precision’s values and complete additional duties as assigned by leadership.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree or equivalent experience ideally in a scientific or health related field
- 10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position
- Experience in managing clinical aspects of complex and global trials
- Previous CTM line management experience
- Working knowledge of ICH GCP guidelines and the clinical development process
Other Required:
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Ability to travel domestically and internationally including overnight stays
Competencies:
- Direct work experience in a global, cross-functional clinical management environment
- Proven experience in people management with a high capacity for Emotional Intelligence
- Ability to develop, coach and mentor CTM staff and hold personnel accountable to achieve goals and address training needs
- Proven experience in risk management and change management
- High level of integrity and must inspire and demand the highest standards from assigned CTMs
- Exhibits high self-motivation, and the ability to work and plan independently as well as in a team environment
- Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
- Excellent presentation, verbal, and written communications skills
- Demonstrated successful independent negotiation and conflict management strategies
- 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 team
#LI-TB1
#LI-Remote
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Manager, Clinical Trial Management
Share this job
Precision for Medicine is growing! We are looking for an experienced Senior Manager, Clinical Trial Management to cover the line management of our Clinical Trial Managers. The position can be covered fully remotely from Spain.
Position Summary:
- The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
- This position requires the ability to independently lead, manage, and motivate a team of CTMs and Managers (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
Essential functions of the job include but are not limited to:
- Lead, mentor, coach, and manage CTMs/PCTMs/MCTMs to support skill development, performance, and career growth in line with Precision for Medicine quality standards.
- Provide leadership and oversight across clinical programs, including clinical trial oversight where applicable.
- Partner with Clinical Operations leadership and cross-functional teams to improve CTM processes, quality, consistency, efficiency, and KPI achievement.
- Collaborate with Resourcing to ensure appropriate staffing and resource allocation.
- Set strategic action plans and provide ongoing performance feedback, technical guidance, and developmental support to direct reports.Ensure CTMs have appropriate training, tools, systems access, and resources to meet role expectations.
- Identify quality risks, recommend corrective actions, and escalate issues as needed to leadership, PMs, and DPMs.Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.
- Develop and update Clinical Operations SOPs, templates, and work instructions; contribute to clinical documentation as needed.
- Support CTM hiring, onboarding, and training in collaboration with HR and Learning & Development.
- Promote Precision’s values and complete additional duties as assigned by leadership.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree or equivalent experience ideally in a scientific or health related field
- 10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position
- Experience in managing clinical aspects of complex and global trials
- Previous CTM line management experience
- Working knowledge of ICH GCP guidelines and the clinical development process
Other Required:
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Ability to travel domestically and internationally including overnight stays
Competencies:
- Direct work experience in a global, cross-functional clinical management environment
- Proven experience in people management with a high capacity for Emotional Intelligence
- Ability to develop, coach and mentor CTM staff and hold personnel accountable to achieve goals and address training needs
- Proven experience in risk management and change management
- High level of integrity and must inspire and demand the highest standards from assigned CTMs
- Exhibits high self-motivation, and the ability to work and plan independently as well as in a team environment
- Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
- Excellent presentation, verbal, and written communications skills
- Demonstrated successful independent negotiation and conflict management strategies
- 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 team
#LI-TB1
#LI-Remote
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine