Job Summary

A clinical development organization has a current position open for a Remote Trial Master File Manager.

Must be able to:

• Serve as the primary point of contact and subject matter expert for TMF processes, systems, and controls
• Provide training, mentorship and onboarding support for Document Management Associates
• Develop the project-specific TMF Plan and TMF Index with input from the Project Manager

Qualifications Include:

• On-the-job or professional training in regulatory document collection and review
• Demonstrated understanding of the TMF Reference Model filing structure, and clinical electronic document management systems
• 5 years industry experience
• 2 years experience working directly with clinical trial documentation