Trial Master File Specialist

Medpace, Inc.•Cincinnati, OH

2d•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 intergrity. 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; and
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.