Trial Master File Specialist

Medpace • Cincinnati, OH

404d

About The Position

The Trial Master File Specialist plays a crucial role in clinical research by managing the Trial Master File (TMF), which is essential for the conduct of clinical trials and maintaining data integrity for regulatory evaluations. This position involves collaboration with a team of TMF specialists and administrators, providing guidance and support to study teams and sponsors, and ensuring compliance with TMF management standards.

Requirements

• Bachelor's degree.
• 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.
• May be responsible for other project and responsibilities, as assigned.

Benefits

• Flexible work environment
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees