Clinical QA TMF Manager

Job Summary

A company is looking for a TMF Manager, Clinical QA.

Key Responsibilities:

• Oversee Trial Master File management across clinical development programs, ensuring documentation is maintained and compliant
• Interface with CROs and external vendors to maintain TMF inspection readiness and support TMF lifecycle activities
• Conduct routine TMF health reviews to identify documentation gaps and ensure appropriate remediation

Required Qualifications:

• Bachelor's degree plus 8 years of experience in life sciences, pharmacy, or related scientific discipline
• Experience in pharmaceutical, biotechnology, or CRO environments with direct involvement in TMF management
• Strong knowledge of regulatory requirements related to clinical trial documentation and TMF management
• Experience with eTMF systems and TMF health review processes
• Familiarity with global Good Clinical Practice (GCP) requirements and regulatory expectations