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Trial Master File Manager Jobs in Seattle, WA (NOW HIRING)

Immunome, Inc.

Clinical Trial Associate

Bothell, WA

$37.50 - $51.25/hr

Manage the electronic Trial Master File (eTMF) for assigned studies, including document processing, metadata quality, periodic QC, and completeness checks. * Support development, review, and ...

Immunome, Inc.

Clinical Trial Associate

Bothell, WA · On-site

$37.50 - $51.25/hr

Manage the electronic Trial Master File (eTMF) for assigned studies, including document processing, metadata quality, periodic QC, and completeness checks. * Support development, review, and ...

NWRPros

Clinical Trial Manager

Seattle, WA · On-site +1

Ensuring completeness and accuracy of Trial Master File * Managing investigational product release packages and investigational product accountability * Performing clinical data review of data ...

NWRPros

Clinical Trial Manager

Bellevue, WA · On-site

Ensuring completeness and accuracy of Trial Master File * Managing investigational product release packages and investigational product accountability * Performing clinical data review of data ...

Jacoby & Meyers

Trial Attorney

Seattle, WA · Remote

Strategically litigate cases by obtaining key evidence to work up case file * Draft mediation ... Regular client communication * Assist in management of litigation assistants and paralegals

New

Jacoby & Meyers

Trial Attorney

Seattle, WA · On-site

Strategically litigate cases by obtaining key evidence to work up case file * Draft mediation ... Regular client communication * Assist in management of litigation assistants and paralegals

New

Jacoby & Meyers

Trial Attorney

Seattle, WA · Remote

Strategically litigate cases by obtaining key evidence to work up case file * Draft mediation ... Regular client communication * Assist in management of litigation assistants and paralegals

New

Nationwide

Trial Attorney

Seattle, WA · On-site

Nationwide Trial Division is a national team with approximately 40 offices through six regions ... g. electronic filings, etc.) Strong time management and organization skills. Decision making ...

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Trial Master File Manager information

See Seattle, WA salary details

$50.6K

$86K

$129.7K

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

As of Aug 1, 2026, the average yearly pay for trial master file manager in Seattle, WA is $86,016.00, according to ZipRecruiter salary data. Most workers in this role earn between $63,200.00 and $106,400.00 per year, depending on experience, location, and employer.

What are some common challenges faced by Trial Master File Managers, and how can they be addressed?

Trial Master File Managers often encounter challenges such as ensuring TMF completeness, maintaining regulatory compliance, and coordinating document submissions across multiple stakeholders. Keeping documents up-to-date and audit-ready requires strong attention to detail and effective communication with clinical teams, vendors, and sponsors. Leveraging electronic TMF systems, implementing standardized processes, and promoting regular training can help address these challenges and ensure the integrity of the TMF throughout a study.

What is a Trial Master File Manager?

A Trial Master File Manager is a professional responsible for overseeing the creation, maintenance, and quality control of the Trial Master File (TMF) in clinical research. The TMF is a collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. The manager ensures that all documents are complete, accurate, and compliant with regulatory requirements throughout the trial's lifecycle. They work closely with clinical teams, auditors, and regulatory authorities to guarantee readiness for inspections and audits. Their role is crucial for maintaining transparency and credibility in clinical research processes.

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

To thrive as a Trial Master File Manager, you typically need a strong background in clinical research, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, GCP guidelines, and relevant industry certifications like DIA's TMF Professional Certification is important. Attention to detail, organizational skills, and effective communication help ensure TMF integrity and coordination across cross-functional teams. These skills are crucial for maintaining regulatory compliance, audit readiness, and efficient clinical trial operations.
What are the most commonly searched types of Trial Master File jobs in Seattle, WA? The most popular types of Trial Master File jobs in Seattle, WA are:
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Trial Master File Manager jobs near you

Trial Master File Lead - TMF

Sound Pharmaceuticals Inc

Seattle, WA • On-site

$80K - $120K/yr

Full-time

Re-posted 10 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.