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Clinical Trial Master File Specialist Jobs (NOW HIRING)

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research ... The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site +1

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research ... The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool ...

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How much do clinical trial master file specialist jobs pay per hour?

As of Sep 1, 2026, the average hourly pay for clinical trial master file specialist in the United States is $43.09, according to ZipRecruiter salary data. Most workers in this role earn between $36.54 and $43.03 per hour, depending on experience, location, and employer.

What is a clinical trial master file specialist?

A Clinical Trial Master File (TMF) Specialist is a professional responsible for organizing, maintaining, and ensuring the completeness and compliance of essential documents related to clinical trials. They manage the TMF, which serves as the central repository for all documentation required by regulatory authorities during a clinical study. TMF Specialists play a critical role in supporting audits and inspections by ensuring that all trial documentation is accurate, up to date, and accessible. Their work helps ensure clinical trials are conducted according to Good Clinical Practice (GCP) and regulatory requirements.

How does a clinical trial master file specialist typically interact with other teams during a clinical study?

A Clinical Trial Master File (TMF) Specialist works closely with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance, to ensure all essential trial documents are collected, reviewed, and maintained according to regulatory requirements. They frequently coordinate with study coordinators, investigators, and project managers to track document submissions, resolve discrepancies, and provide updates on TMF status. This collaboration is crucial to maintaining inspection readiness and supporting the overall success of clinical studies.

What are the key skills and qualifications needed to thrive as a clinical trial master file specialist, and why are they important?

To thrive as a Clinical Trial Master File (TMF) Specialist, you need a strong understanding of clinical research processes, regulatory requirements, and document management, typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, Good Clinical Practice (GCP) guidelines, and quality assurance tools is essential. Excellent organizational skills, attention to detail, and effective communication set outstanding TMF Specialists apart. These capabilities ensure clinical trial documentation is accurate, inspection-ready, and compliant, which is critical for successful regulatory submissions and trial integrity.

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

AspectClinical Trial Master File SpecialistClinical Research Coordinator
CredentialsTypically requires a degree in life sciences or healthcare, with certifications like eTMF or clinical trial documentation trainingRequires a degree in health sciences or related field; often certified as CRC or through GCP training
Work EnvironmentWorks primarily in document management, compliance, and regulatory teams within pharmaceutical or biotech companiesManages patient recruitment, site coordination, and study logistics at research sites or hospitals
Employer & IndustryPharmaceutical companies, CROs, biotech firmsHospitals, research institutions, clinical trial sites

The Clinical Trial Master File Specialist focuses on managing and maintaining essential trial documentation to ensure regulatory compliance, while the Clinical Research Coordinator handles the day-to-day operations of clinical trials at research sites. Both roles require knowledge of GCP and clinical trial processes but serve different functions within the clinical research ecosystem.

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Clinical Trial Master File Specialist jobs near you
Infographic showing various Clinical Trial Master File Specialist job openings in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 71% In-person, and 29% Remote job distribution, with an average salary of $89,619 per year, or $43.1 per hour.

Trial Master File Specialist

Medpace, Inc.

Cincinnati, OH • On-site

$32.25 - $44/hr

Other

Medical, Retirement, PTO

Re-posted 6 days ago

Medpace rating

8.6

Company rating: 8.6 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

14th of 74 rated research

Job description

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 all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you will be working with a highly experienced team of administrators, specialists, and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is office-based in Cincinnati, OH.
Responsibilities
  • Provide guidance and support to study team members and sponsors regarding TMF management;
  • Initiate and manage TMF Specifications based on scope of work, protocol, and other core documents working with functional area leads and sponsor contacts;
  • Set up and maintain study specific TMF folder structure;
  • Support CTMs with review of TMF Plans as required;
  • Support study team(s) during periodic TMF QCs by assisting with report development and metric reporting;
  • Report on TMF Health to Sponsors and CTMs;
  • Contribute to audit/inspection readiness activities by reviewing the TMF, TMF Specifications, and TMF Plans for accuracy, consistency, and completeness;
  • Train and mentor other TMF staff; and
  • help with other project and responsibilities, as assigned.

Qualifications
  • Bachelor's degree, life science field preferred
  • Proficient knowledge of Microsoft® Office and Adobe Acrobat®
  • Computer literacy (i.e., ability to file, scan, create folders, and organize files using various
  • software);
  • Ability to accurately and carefully follow procedures for completing work tasks; and
  • Ability to perform repetitive work without losing effectiveness/accuracy.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
    • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture
    • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
    • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development
    • Office based environment with on-site mentors
    • Defined career paths with clear advancement opportunities
    • Industry renowned onboarding and training programs designed to accelerate professional development
    • Ongoing training and continuous learning opportunities throughout your career
    • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits
    • Competitive compensation programs that recognize and reward performance
    • Comprehensive health, wellness, retirement, and PTO benefits
    • Office based culture with occasional WFH that provides flexibility for eligible positions after training
    • Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience
    • A modern corporate campus designed to support collaboration and productivity
    • Multiple on-site dining options in the heart of Madison Square
    • Free on-site parking
    • Convenient access to on-site 24-7 fitness and wellness facilities

What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

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About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992

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