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Trial Master File Manager Jobs (NOW HIRING)

NWRPros

Clinical Trial Manager

Bellevue, WA

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

Galderma

Clinical Trial Assistant

Boston, MA

Overall responsibility of Trial Master File (TMF): set up, maintenance and archiving for in-sourced ... The next step is a virtual conversation with the hiring manager * The final step is a panel ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH

$32.25 - $44/hr

Job Summary We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores ...

Crinetics Pharmaceuticals

Clinical Trial Associate

$34.25 - $46.75/hr

Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples) * Maintain the Trial Master File for all clinical projects * Perform periodic reviews and QC of the ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

US Tech Solutions

Specialist Study Management

Wilmington, DE · On-site

$33.75 - $45.25/hr

Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File ... Display excellent organization and time management skills, excellent attention to detail, and ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH · On-site

$32.25 - $44/hr

Job Summary We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores ...

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

As of May 31, 2026, the average yearly pay for trial master file manager in the United States is $75,583.00, according to ZipRecruiter salary data. Most workers in this role earn between $55,500.00 and $93,500.00 per year, depending on experience, location, and employer.

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 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.
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Trial Master File Manager jobs near you
Infographic showing various Trial Master File Manager job openings in the United States as of May 2026, with employment types broken down into 94% Full Time, and 6% Contract. Highlights an 83% In-person, 11% Hybrid, and 6% Remote job distribution, with an average salary of $75,583 per year, or $36.3 per hour.

Clinical Trial Manager

NWRPros

Bellevue, WA

Full-time

Posted 28 days ago

Job description

Our client is an innovative clinical-stage biotechnology company advancing next-generation therapeutics through proprietary localized, extended-release drug delivery technology. Their platform is designed to precisely target treatment to specific tissues, with the potential to enhance safety, tolerability, efficacy, and duration of effect while reducing systemic exposure and side effects often associated with conventional delivery methods. The company is currently progressing programs in pain and inflammatory gastrointestinal disease, with broader future applications across oncology, infectious disease, and other areas of significant unmet medical need. This is an exciting opportunity to join a science-driven organization focused on transforming how established and novel therapies are delivered to patients.
Scope:
As our client’s Clinical Trial Manager (CTM) you will be primarily responsible for the operational management and oversight of clinical studies. You will also help us build our clinical operational infrastructure and teams.
Travel Requirement: Must be willing to travel domestically and internationally (approximately 20%), as needed
Primary Responsibilities:
  • Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
  • Independently developing the trial’s timelines, budgets, key deliverables, and risk/mitigation strategies
  • Leading the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
  • Planning and leading study team meetings
  • Managing, mentoring, and training clinical operational staff
  • Leading the identification and engagement of CROs and other third-party study vendors
  • Managing and improving performance of third party vendors and field CRAs to ensure compliance with study protocol and consistency with scope of work; identify areas of concern and escalate as appropriate
  • Identifying, selecting, and monitoring performance of investigational sites; ensuring accurate and timely site visit reports
  • Developing and maintaining good working relationships with investigators and study staff
  • Negotiating and managing the budgets and payments for investigative sites
  • Tracking and ensuring optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
  • Ensuring completeness and accuracy of Trial Master File
  • Managing investigational product release packages and investigational product accountability
  • Performing clinical data review of data listings and summary tables, including query generation
  • Other duties as assigned
 
Job Qualifications and Requirements:
  • Bachelor’s degree or equivalent in life sciences
  • At least 6 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
  • At least 1 year of experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee
  • Ability to plan, organize and conduct clinical trials with minimum oversight
  • Experience leading, managing, or mentoring clinical operational staff and cross-functional teams
  • Significant experience managing CROs and other vendors and assessing performance and finances (e.g., invoice review, change order management, and budget reforecasting)
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Able to motivate a team to work effectively
  • Able to solve problems under pressure