Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Quick apply
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Quick apply
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Durham, NC · On-site
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Durham, NC · On-site
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Files trial records in the TMF and performs regular TMF checks on a site and country level * Participates in and follows up on TMF and systems audits * Prepares, distributes, and updates Investigator ...
Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections * Reviews and coordinates site-specific query resolution * Reviews and coordinates site-specific EDC ...
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Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections * Reviews and coordinates site-specific query resolution * Reviews and coordinates site-specific EDC ...
Durham, NC · On-site
Coordinates preparation for and follow-up on site, TMF and systems' audits and inspections * Reviews and coordinates site-specific query resolution * Reviews and coordinates site-specific EDC ...
Durham, NC · On-site
Coordinates preparation for and follow-up on site, TMF and systems' audits and inspections * Reviews and coordinates site-specific query resolution * Reviews and coordinates site-specific EDC ...
Durham, NC · On-site
$71K - $145K/yr
... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP ...
Durham, NC · On-site
$71K - $145K/yr
... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP ...
Durham, NC · On-site
$71K - $145K/yr
... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP ...
Durham, NC · On-site
$71K - $145K/yr
... site TMF documents in study start-up to ensure TMF inspection readiness Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP ...
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 ...
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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 ...
Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates and monitors the activities associated with study deliverables across all applicable internal ...
Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates and monitors the activities associated with study deliverables across all applicable internal ...
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 ...
Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates and monitors the activities associated with study deliverables across all applicable internal ...
Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates and monitors the activities associated with study deliverables across all applicable internal ...
Durham, NC · On-site
$32.25 - $44.25/hr
Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable. * Audit and CAPA tracking. * Set up and ...
Durham, NC · On-site
$32.25 - $44.25/hr
Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable. * Audit and CAPA tracking. * Set up and ...
Provide subject matter expertise across Veeva systems (CTMS, TMF, SRD), ensuring appropriate usage, governance, and issue resolution Resource Management & Planning Enablement * Partner with SDL ...
Provide subject matter expertise across Veeva systems (CTMS, TMF, SRD), ensuring appropriate usage, governance, and issue resolution Resource Management & Planning Enablement * Partner with SDL ...
Ensure all relevant documents are submitted to the TMF as per requirements. * May be assigned to coach, mentor or on-board new hires or junior Specialists * Contributes into functional improvement ...
Ensure all relevant documents are submitted to the TMF as per requirements. * May be assigned to coach, mentor or on-board new hires or junior Specialists * Contributes into functional improvement ...
Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares for and follows up on system audits and inspections * Supervises the preparation, distribution, and ...
Quick apply
Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares for and follows up on system audits and inspections * Supervises the preparation, distribution, and ...
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations. * Mentorship: Mentor clinical staff through co ...
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations. * Mentorship: Mentor clinical staff through co ...
Durham, NC · On-site
$69K - $226K/yr
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations. * Mentorship: Mentor clinical staff through co ...
Durham, NC · On-site
$69K - $226K/yr
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations. * Mentorship: Mentor clinical staff through co ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares for and follows up on system audits and inspections * Supervises the preparation, distribution, and ...
Durham, NC · On-site
Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares for and follows up on system audits and inspections * Supervises the preparation, distribution, and ...
$16.82 - $21.50
4% of jobs
$21.50 - $26.17
8% of jobs
$26.17 - $30.84
12% of jobs
$30.98 is the 25th percentile. Wages below this are outliers.
$30.84 - $35.52
26% of jobs
$35.52 - $40.19
18% of jobs
$41.81 is the 75th percentile. Wages above this are outliers.
$40.19 - $44.86
19% of jobs
$44.86 - $49.54
6% of jobs
$49.54 - $54.21
2% of jobs
$54.21 - $58.88
1% of jobs
$58.88 - $63.56
1% of jobs
$63.56 - $68.23
2% of jobs
$16
$38
$68
To thrive as a TMF (Trial Master File) Specialist, you need a solid understanding of clinical trial documentation, regulatory guidelines (such as ICH-GCP), and strong organizational skills, typically supported by experience in clinical research or a related life sciences field. Proficiency with electronic Trial Master File (eTMF) systems, document management software, and sometimes certifications like DIA TMF or clinical research certification are commonly required. Attention to detail, effective communication, and the ability to manage deadlines are important soft skills in this role. These competencies ensure regulatory compliance, efficient document retrieval, and successful clinical trial audits.
A TMF (Trial Master File) job typically involves managing and maintaining essential documents related to clinical trials. Professionals in this role ensure that all trial documentation complies with regulatory requirements and is audit-ready. They may work with electronic TMF (eTMF) systems, collaborate with study teams, and ensure document accuracy and completeness. TMF specialists play a crucial role in supporting clinical research compliance and regulatory submissions.
As a TMF Specialist, your daily responsibilities include maintaining and updating essential clinical trial documents, ensuring accurate filing and compliance with regulatory standards, and performing routine quality checks on documentation. You will collaborate closely with clinical operations, project managers, and external stakeholders to gather and validate needed materials. Attention to deadlines and meticulous organization are critical, as audits and inspections may require quick access to correctly archived files. This hands-on role is vital for ensuring that all documentation is complete, accurate, and ready for review throughout the life cycle of a clinical trial.

Full-time
Posted 18 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.