TMF Lead

Job Summary

A company is looking for a TMF Lead to oversee Trial Master File management processes in compliance with regulatory requirements.

Key Responsibilities

• Lead the setup, maintenance, and oversight of the TMF in compliance with regulatory standards
• Collaborate with cross-functional teams to ensure timely and accurate documentation within the TMF
• Conduct regular TMF quality checks and audits to identify and resolve discrepancies

Required Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred
• Proven experience in TMF management or clinical trial document management
• Strong understanding of regulatory requirements related to TMF and clinical documentation
• Excellent organizational skills ensuring compliance and accuracy in TMF management
• Commitment to promoting equity and inclusion in TMF management