Trial Master File Specialist

Medpace, Inc. • Cincinnati, OH

6d • Onsite

About The Position

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.

Requirements

• 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;
• Ability to perform repetitive work without losing effectiveness/accuracy.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level