Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Quick apply
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Quick apply
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Project Manager - Future roles (US) Syneos Health is a leading fully integrated biopharmaceutical ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Project Manager - Future roles (US) Syneos Health is a leading fully integrated biopharmaceutical ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Project Manager - Future roles (US) Syneos Health ® is a leading fully integrated ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Project Manager - Future roles (US) Syneos Health ® is a leading fully integrated ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Quick apply
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Durham, NC · On-site
Coordinates preparation for and follow-up on site, TMF and systems' audits and inspections ... Provides training in courier management and study supplies ordering to the site team Document ...
Durham, NC · On-site
Coordinates preparation for and follow-up on site, TMF and systems' audits and inspections ... Provides training in courier management and study supplies ordering to the site team Document ...
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities Prepares ... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to ...
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities Prepares ... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to ...
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities Prepares ... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to ...
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities Prepares ... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to ...
Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management. * Oversight and approval of site payments, including payment reconciliation.
Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management. * Oversight and approval of site payments, including payment reconciliation.
Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management. * Oversight and approval of site payments, including payment reconciliation.
Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management. * Oversight and approval of site payments, including payment reconciliation.
Durham, NC · On-site
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · On-site
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · On-site
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · On-site
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · Hybrid
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · Hybrid
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · Hybrid
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Durham, NC · Hybrid
$80K - $90K/yr
You will report to the Senior Manager - Payroll and use a hybrid work schedule. You Will ... Experience working with payroll vendors (e.g., ADP SmartCompliance, TMF, local providers)
Responsible for quality and completeness of TMF for assigned projects. * Accountable for maintenance of study information on a variety of databases and systems. * Responsible for study management ...
Responsible for quality and completeness of TMF for assigned projects. * Accountable for maintenance of study information on a variety of databases and systems. * Responsible for study management ...
Responsible for quality and completeness of TMF for assigned projects. * Accountable for maintenance of study information on a variety of databases and systems. * Responsible for study management ...
Responsible for quality and completeness of TMF for assigned projects. * Accountable for maintenance of study information on a variety of databases and systems. * Responsible for study management ...
Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance , data accuracy, and documentation completeness. * Manage or contribute to the tracking of low-stability endpoint ...
Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance , data accuracy, and documentation completeness. * Manage or contribute to the tracking of low-stability endpoint ...
$28.04 - $33.99
4% of jobs
$33.99 - $39.93
6% of jobs
$39.93 - $45.88
7% of jobs
$50.34 is the 25th percentile. Wages below this are outliers.
$45.88 - $51.83
9% of jobs
$51.83 - $57.78
15% of jobs
The median wage is $60.40 / hr.
$57.78 - $63.73
18% of jobs
$67.96 is the 75th percentile. Wages above this are outliers.
$63.73 - $69.67
21% of jobs
$69.67 - $75.62
7% of jobs
$75.62 - $81.57
6% of jobs
$81.57 - $87.52
3% of jobs
$87.52 - $93.46
2% of jobs
$28
$60
$93
TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.
To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.
A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.

Full-time
Posted 5 days ago
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job DescriptionStart your career in clinical research, streamlining communication, maintaining systems and managing documents.
The scope of responsibilities will include:
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.