Entry-Level TMF Specialist – Clinical Research

Medpace; Cincinnati (OH); On-site; USD 38,000 - 58,000; Full time

Job summary

Medpace, a Cincinnati-based clinical research organization, is hiring entry-level professionals to join our Trial Master File (TMF) team. You will work with a skilled group of administrators and clinical research professionals to learn TMF processes and support trial documentation in a fast-paced environment.

This office-based role emphasizes attention to detail, adherence to procedures, and collaboration with study teams and sponsors.

Qualifications

• Bachelor's degree in life science field preferred.
• Proficient knowledge of Microsoft Office and Adobe Acrobat.
• Computer literacy: filing, scanning, creating folders, organizing files.

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.

Skills

Attention to detail

Follow procedures

Team collaboration

Communication skills

Education

Bachelor's degree, life science field preferred

Tools

Microsoft Office

Adobe Acrobat

Job description

Medpace, a Cincinnati-based clinical research organization, is hiring entry-level professionals to join our Trial Master File (TMF) team. You will work with a skilled group of administrators and clinical research professionals to learn TMF processes and support trial documentation in a fast-paced environment.

This office-based role emphasizes attention to detail, adherence to procedures, and collaboration with study teams and sponsors.