TMF Program Lead

Job Summary

A company is looking for a TMF Program Lead.

Key Responsibilities

• Oversee TMF management and identify strategies for improvement
• Conduct trend analysis of TMF metrics and recommend enhancements
• Manage inspection readiness and support audit preparations

Required Qualifications, Training, and Education

• 5 years in a TMF Study Owner or equivalent role
• In-depth knowledge of Good Documentation Practices (GDP) and TMF Reference Model
• Excellent understanding of clinical trial and TMF lifecycles
• Familiarity with eTMF systems and document management systems
• Experience in training and mentoring related to TMF operations