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Director Trial Master File Jobs (NOW HIRING)

Pathos

Clinical Trial Assistant

New York, NY · On-site

$75K - $85K/yr

This means maintaining our Trial Master File, coordinating with CROs and sites, managing documentation across multiple programs, and ensuring every submission to FDA is inspection-ready. What makes ...

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 ...

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 ...

Galderma

Clinical Trial Assistant

Boston, MA

... direct impact. Job Title: Clinical Trial Administrator Location: Boston The CTA (Clinical Trial ... Overall responsibility of Trial Master File (TMF): set up, maintenance and archiving for in-sourced ...

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Director Trial Master File information

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$45K

$128.4K

$232.5K

How much do director trial master file jobs pay per year?

As of May 31, 2026, the average yearly pay for director trial master file in the United States is $128,367.00, according to ZipRecruiter salary data. Most workers in this role earn between $58,000.00 and $188,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director Trial Master File, and why are they important?

To thrive as a Director Trial Master File, you need deep knowledge of clinical trial processes, regulatory guidelines (such as GCP and ICH), and extensive experience in TMF management, often supported by a relevant degree and prior leadership in clinical operations. Expertise with electronic Trial Master File (eTMF) systems, document management platforms, and familiarity with industry certifications like DIA TMF Practitioner are highly valued. Strong leadership, attention to detail, and excellent communication skills distinguish top performers in this role. These capabilities ensure regulatory compliance, audit readiness, and effective oversight of clinical trial documentation, which are critical for successful drug development.

What are some common challenges a Director of Trial Master File faces when ensuring TMF completeness and inspection readiness?

A Director of Trial Master File often encounters challenges related to maintaining TMF completeness across multiple studies and vendors, ensuring timely document submission, and preparing for regulatory inspections. Coordinating efforts among cross-functional teams—including clinical operations, regulatory affairs, and external partners—can be complex, especially when aligning on documentation standards and resolving discrepancies. Proactive communication, robust quality control processes, and familiarity with evolving regulatory requirements are key to overcoming these challenges and ensuring inspection readiness.

What are Director Trial Master File roles and responsibilities?

A Director of Trial Master File (TMF) oversees the management and quality of TMF systems, which are essential for documenting the conduct of clinical trials. They ensure that all trial documentation is complete, accurate, and compliant with regulatory requirements. This role involves developing TMF strategies, leading teams, implementing best practices, and collaborating with clinical, regulatory, and quality assurance departments to support clinical trial audits and inspections. The director also manages TMF vendors, monitors key performance indicators, and drives process improvements.

What is the difference between Director Trial Master File vs Clinical Trial Coordinator?

AspectDirector Trial Master FileClinical Trial Coordinator
CredentialsAdvanced degrees (e.g., Life Sciences, Healthcare), experience in clinical trial documentationBachelor's degree, certification in clinical research preferred
Work EnvironmentSenior management, overseeing TMF processes across projectsOperational role, supporting trial activities at site or sponsor level
Industry UsageUsed in pharmaceutical, biotech, and CRO settings for document oversightCommonly employed in clinical sites and research organizations

The Director Trial Master File focuses on strategic oversight and management of trial documentation, ensuring compliance and quality. In contrast, the Clinical Trial Coordinator handles day-to-day trial activities, including document collection and site coordination. Both roles are essential but differ in scope, responsibilities, and seniority within the clinical research process.

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Director Trial Master File jobs near you
Infographic showing various Director Trial Master File job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 78% In-person, and 22% Remote job distribution, with an average salary of $128,367 per year, or $61.7 per hour.
Trial Master File Lead - TMF

Trial Master File Lead - TMF

Sound Pharmaceuticals Inc

Seattle, WA • On-site

$80K - $120K/yr

Full-time

Posted 9 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.