TMF Operations Manager

Job Summary

A company is looking for a TMF Operations Manager to oversee the management and quality control of Trial Master File documentation across global studies.

Key Responsibilities

• Oversee the strategic management and continuous improvement of the Trial Master File (TMF) across clinical studies
• Lead TMF quality review activities and ensure the accuracy, completeness, and accessibility of required documents
• Prepare for and support audits related to the TMF, including documentation preparation and resolution of audit findings

Required Qualifications

• Bachelor's degree or equivalent in a science or health-related field
• Minimum 5 years of clinical operations experience, including global trial experience
• Thorough knowledge of CDISC TMF Reference Model and relevant regulatory standards
• Experience with eTMF systems and development of training materials and SOPs
• Prior participation in regulatory health inspections is preferred