Trial Master File Specialist

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 core documents
• Set up and maintain study-specific TMF folder structures
• Support Clinical Trial Managers (CTMs) with the review of TMF Plans
• Assist with periodic TMF quality checks, report development, and metric reporting
• Report on TMF health to Sponsors and CTMs
• Contribute to audit and inspection readiness by reviewing TMF documentation for accuracy and completeness
• Train and mentor other TMF staff members

Requirements

• Bachelor's degree
• Proficient knowledge of Microsoft Office and Adobe Acrobat
• Strong computer literacy, including the ability to file, scan, and organize digital files
• Ability to accurately and carefully follow established procedures
• High attention to detail and the ability to perform repetitive tasks without losing effectiveness

Preferred Qualifications

• Bachelor's degree in a Life Science field

Benefits

• Competitive compensation and benefits package
• Competitive PTO packages starting at 20+ days
• Structured career paths with professional growth opportunities
• Modern, eco-friendly campus with an on-site fitness center
• Employee health and wellness initiatives
• Company-sponsored employee appreciation events
• Discounts on local sports, fitness, and attractions

About the Company

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace leverages scientific and disciplined approaches to accelerate the global development of safe and effective medical therapeutics.