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Trial Master File Jobs (NOW HIRING)

Celerion

Trial Master Files Representative

$25 - $28/hr

... a Full-Time Trial Master Files Representative to join our team. This is a remote, home-based ... You will be responsible for maintenance of the TMF, creating a file structure and indexing contents.

Cellectis

Clinical Trial Associate

Manhattan, NY · On-site

$36.75 - $50.25/hr

This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...

Cellectis

Clinical Trial Associate

Manhattan, NY

$36.75 - $50.25/hr

This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...

StartX

Clinical Trial Associate

Redwood City, CA · On-site

$41 - $56/hr

Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs, the TMF Reference Model, and applicable regulatory requirements, including ICH-GCP. * Help ensure ...

StartX

$24.75 - $33.75/hr

Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs, the TMF Reference Model, and applicable regulatory requirements, including ICH-GCP. * Help ensure ...

Karius, Inc.

$24.75 - $33.75/hr

Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs, the TMF Reference Model, and applicable regulatory requirements, including ICH-GCP. * Help ensure ...

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How much do trial master file jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for trial master file in the United States is $39.72, according to ZipRecruiter salary data. Most workers in this role earn between $25.72 and $48.32 per hour, depending on experience, location, and employer.

What is a trial master file?

A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.

What are the typical responsibilities and daily tasks of a trial master file specialist?

As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.

What are the key skills and qualifications needed to thrive in the trial master file position, and why are they important?

To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.

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Trial Master File jobs near you
Infographic showing various Trial Master File job openings in the United States as of September 2026, with employment types broken down into 70% Full Time, 12% Temporary, and 18% Contract. Highlights an 82% In-person, and 18% Remote job distribution, with an average salary of $82,616 per year, or $39.7 per hour.

Trial Master File Lead - TMF

Seattle, WA • On-site

Sound Pharmaceuticals Inc
Pharmaceutical and Medicine Manufacturing • 11 - 50 employees
Learn more about Sound Pharmaceuticals Incexternal

$80K - $120K/yr

Full-time

Re-posted 24 days ago

Job description

Reports to: Reports to the VP, Clinical Operations 
SPI is seeking a highly experienced and organized TMF Lead to support the operational execution of our clinical research programs. 
As a TMF Lead, you will lead the smooth execution of clinical trials from start-up to close-out, work closely with CRA(s) and cross-functional teams to ensure our studies are conducted efficiently, on time, and in full compliance with ICH-GCP and regulatory standards. This role offers hands-on experience and a clear pathway for career growth.  
Key Responsibilities:
Perform the following duties and responsibilities in support of SPI’s clinical research programs from start-up to close-out: clinical trial support, operational coordination, compliance and quality, communication and collaboration, and continuous improvement. The TMF Lead shall perform the foregoing duties diligently, professionally, and in accordance with applicable laws, regulations, Good Clinical Practice (GCP), E6 ICH Guidelines, and SPI’s relevant regulations and Standard Operating Procedures (SOPs) within the DIA Reference Model. From time to time, additional or incidental duties may reasonably be assigned by SPI, provided such duties are consistent with the position and scope of responsibilities. 
Clinical Trial Support
·       Assist in the coordination, implementation, and tracking of clinical trials from start-up through closeout.
·       Prepare, collect, review, and maintain essential regulatory and study documentation, including the Trail Master File (TMF) and within the DIA Reference Model, and associated electronic systems.
·       Support the preparation and submission of regulatory and ethics committee documentation as required.
Operational Coordination
·       Provide advanced administrative and logistical support to Clinical Research Associates (CRAs) and Regulatory Manager in the conduct of clinical studies.
·       Coordinate the shipment and tracking of study supplies, investigational medicinal product (IMP), and related materials. 
·       Maintain accurate and up-to-date study trackers, reports, and databases to monitor study progress, enrollment, and milestones. 
Compliance and Quality
·       Ensure that all documentation and study activities comply with applicable laws, regulations, Good Clinical Practice (GCP), E6 ICH Guidelines, and SPI’s relevant regulations and Standard Operating Procedures (SOPs).
·       Assist with internal and external audits, inspections, and ensure continuous TMF inspection readiness. 
·       Conduct quality control (QC) reviews of clinical trial documents and systems to ensure data accuracy and completeness.
Communication and Collaboration
·       Serve as liaison between internal teams, investigator sites, and external vendors to ensure efficient communication and coordination of study activities. 
·       Support the preparation of agendas, meeting materials, and minutes for study-related meetings.
·       Support the creation and maintenance of study materials, including but not limited to site and CTA/ CRA training materials, regulatory document templates, study binders, study plans, study communications and presentations.
Continuous Improvement
·       Participate in process improvement initiatives to enhance operational efficiency within Clinical Operations.
·       Provide guidance and mentorship to junior Clinical Trial Assistants (CTAs) and support staff as required. 
Qualifications:
Education
·       Bachelor’s degree in life sciences or health-related field strongly desired. 
Experience
·       5 – 7+ years of experience in CTA or clinical operations in pharmaceuticals, biotech, or CROs.
·       Strong understanding of ICH-GCP, regulatory guidelines, and clinical trials processes.
·       Experience supporting global, multi-center clinical studies.
·       Experience with eTMF and CTMS systems (e.g., DIA Reference Model).
·       Familiarity with audit/inspection preparation.
·       Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. 
·       Proficient in SharePoint, MS Outlook, Word, PowerPoint and Excel products.
Other Requirements
·       Excellent attention to detail, time-management, and organizational skills to manage projects efficiently. 
·       Excellent communication skills, both oral and written. 
·       Ability to work both independently and collaboratively in a fast-paced environment.
·       Project management capabilities. 
·       Understand implications of work and make recommendations for solutions. 
·       Determine methods and procedures on new assignments. Identify areas for process or technology improvements with regard to tasks within the role. 
·       Interact with Investigator sites for activities such as to collect relevant documentation and study materials as needed.
·       From time to time, additional or incidental duties may reasonably be assigned by SPI, provided such duties are consistent with the position and scope of responsibilities. 
We offer competitive salaries and an excellent benefits package. Successful incumbent will be able to grow into CRA or Clinical Research roles through structured mentorship and internal promotions, as well as play a key role in improving patient outcomes and medical innovation. Sound Pharmaceuticals, Inc is an Equal Opportunity Employer.
If interested in pursuing an interview, please also email your resume to jsullivan@soundpharma.com.  If you do not email your resume with a note, you will not get any response.