Entry-Level Trial Master File (TMF) Specialist

About the Role

We are currently hiring entry-level individuals seeking an exciting career in clinical research, managing our Trial Master File (TMF). The TMF is an integral tool that stores all data and research collected on a given trial, allowing for effective trial management and ensuring data integrity. TMF oversight plays a significant role in the successful execution of a trial and the approval of new drugs or devices 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.

Key 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.
• Help with other project and responsibilities, as assigned.

Qualifications

• 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.