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# Trial Master File Specialist

- **Company:** MEDPACE
- **Location:** Cincinnati, OH, United States (Remote available)
- **Contract:** Permanent contract
- **Skills:** Clinical Trial Management Systems, Computer Literacy, Data Integrity, Microsoft Office, Requirements Management, Clinical Data Management System, Adobe
- **Published:** November 2, 2026
- **Apply:** https://www.careerbuilder.com/job-details/trial-master-file-specialist-cincinnati-oh--ba20866d-ab47-410b-bbf1-c9ef1dade914

## About the Role

FDA (Food and Drug Administration), Clinical Research, Clinical Trial, Team Lead/Manager, Data Quality, Team Player, Data Collection, People Management, Requirements Management, Metrics, * 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.

## Description

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.