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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.
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
Share this job
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.
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
Share this job
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.
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
Share this job
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.
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
Share this job
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.
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
Share this job
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.
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
Share this job
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.
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
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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.
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
Share this job
The Senior Manager, Medical Advisory and Research is responsible for ensuring clinical excellence, scientific rigor, and high-quality medical advisory delivery across EVYD’s products, research initiatives, and external engagements.
This role serves as the medical advisory execution lead under the Head of Medical, with formal clinical sign-off authority, ownership of selected research initiatives, and direct management of the research team. The role bridges medical advisory, research execution, product development, and commercial support to ensure all outputs are scientifically sound, clinically appropriate, and aligned with EVYD's strategic objectives.
Serve as the medical advisory lead for EVYD’s products, programs, and solutions, ensuring clinical accuracy, relevance, and compliance with current medical standards and guidelines.
Provide formal clinical and scientific sign-off on medical content, research outputs, protocols, advisory materials, and clinical workflows within delegated authority.
Act as the primary medical and scientific approver for assigned initiatives, with escalation to the Head of Medical where required.
Review and assess medical assumptions, intervention logic, and outcome frameworks embedded in digital health, population health, and research solutions.
Advise internal teams on clinical workflows, patient journeys, and healthcare delivery processes across prevention, diagnosis, treatment, and follow-up.
Stay current with medical literature, guidelines, and industry developments, translating evidence into actionable advisory input.
Supervise and coordinate research execution carried out by senior associates and analysts, ensuring projects are delivered on time, within scope, and to required scientific standards.
Own and lead selected research projects end-to-end, including study design, methodology, execution oversight, analysis interpretation, and dissemination.
Review and approve research concepts, study designs, protocols, analysis plans, and manuscripts prior to submission or publication.
Ensure effective use of real-world data, electronic medical records, registries, and digital health data in research initiatives.
Support the development of research proposals, grant applications, ethics submissions, and collaboration agreements where required.
Provide research-backed and clinically sound input into product design, localization, and enhancement, particularly for population health and digital therapeutics solutions.
Support commercial and business development activities by contributing medical and scientific expertise to proposals, presentations, and client discussions.
Engage external stakeholders including clinicians, researchers, partners, and institutional collaborators to support advisory, research, and business objectives.
Represent EVYD in relevant conferences, workshops, seminars, and thought leadership activities as a medical and research subject matter expert.
Line-manage the Senior Associate, Research and Analyst, Research, providing clear direction, supervision, and performance management.
Build team capability in research quality, scientific communication, and clinical reasoning.
Establish, refine, and scale standard operating procedures (SOPs), quality standards, and review processes for medical advisory and research outputs.
Foster a culture of accountability, scientific rigor, and continuous learning within the team.
This role will require occasional travel, up to 20% of the time, to meet our clients and stakeholders in our countries of business.
Medical degree (MD or equivalent) required; active clinical practice is not mandatory.
Relevant postgraduate training in public health, research, or related fields is an advantage.
Typically 7–12 years of experience across clinical practice, medical advisory, research, or healthcare technology environments, with demonstrated capability in medical advisory and research leadership.
Experience in health technology, population health, digital health, or applied clinical research is highly desirable.
Publication experience is an advantage but not mandatory.
Strong written and verbal communication skills in English; additional languages are an advantage.
Ready to apply?
Apply to EVYD Technology
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Build and expand relationships with stakeholders across the Singapore healthcare ecosystem (hospitals, clinics, clusters, insurers, life sciences, and community partners).
Meet clients regularly to understand their pain points, strategic priorities, and digital transformation needs.
Identify business opportunities, gather requirements, and translate them into potential product or project scopes.
Support market expansion efforts by identifying new opportunities and building connections with ecosystem partners.
Conduct research on overseas healthcare ecosystems to support EVYD’s international growth strategy.
Work closely with EVYD’s product, technology, and project teams to shape proposals and follow through on engagements.
Support tender preparation, proposal writing, and solution pitching.
Track market trends, competitor offerings, and regulatory updates relevant to healthcare and digital health.
Assist in the planning and execution of pilots, workshops, and ecosystem events.
Maintain accurate reporting of pipelines, interactions, and follow-up actions.
Undertake any other responsibilities or assignments delegated by management to support business needs.
Experience: 3-5 years in business development, partnerships, consulting, or project roles in healthcare or health-related sectors.
Strong understanding of the Singapore healthcare ecosystem, such as public clusters, primary care, community care, insurers, and regulatory bodies.
Experience engaging clients and running meetings professionally.
Knowledge of health technology, digital health, or data/AI solutions is highly desirable.
Familiarity with project management processes is a plus.
Strong communication, stakeholder management, and presentation skills.
Self-driven, resourceful, and comfortable operating in a fast-paced environment.
Ability to work independently while collaborating closely with regional teams.
Opportunity to help shape national-level digital health solutions across the region.
Work with a dynamic, mission-driven team at the intersection of healthcare and advanced technology.
Exposure to cutting-edge AI and population health platforms.
Ready to apply?
Apply to EVYD Technology
Share this job
Build and expand relationships with stakeholders across the Singapore healthcare ecosystem (hospitals, clinics, clusters, insurers, life sciences, and community partners).
Meet clients regularly to understand their pain points, strategic priorities, and digital transformation needs.
Identify business opportunities, gather requirements, and translate them into potential product or project scopes.
Support market expansion efforts by identifying new opportunities and building connections with ecosystem partners.
Conduct research on overseas healthcare ecosystems to support EVYD’s international growth strategy.
Work closely with EVYD’s product, technology, and project teams to shape proposals and follow through on engagements.
Support tender preparation, proposal writing, and solution pitching.
Track market trends, competitor offerings, and regulatory updates relevant to healthcare and digital health.
Assist in the planning and execution of pilots, workshops, and ecosystem events.
Maintain accurate reporting of pipelines, interactions, and follow-up actions.
Undertake any other responsibilities or assignments delegated by management to support business needs.
Experience: 3-5 years in business development, partnerships, consulting, or project roles in healthcare or health-related sectors.
Strong understanding of the Singapore healthcare ecosystem, such as public clusters, primary care, community care, insurers, and regulatory bodies.
Experience engaging clients and running meetings professionally.
Knowledge of health technology, digital health, or data/AI solutions is highly desirable.
Familiarity with project management processes is a plus.
Strong communication, stakeholder management, and presentation skills.
Self-driven, resourceful, and comfortable operating in a fast-paced environment.
Ability to work independently while collaborating closely with regional teams.
Opportunity to help shape national-level digital health solutions across the region.
Work with a dynamic, mission-driven team at the intersection of healthcare and advanced technology.
Exposure to cutting-edge AI and population health platforms.
Ready to apply?
Apply to EVYD Technology
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