TMF Quality Project Manager

About the role

Serve as the liaison between Records Management and user departments for Trial Master Files, providing project‑related assistance across multiple studies and sites while ensuring compliance with SOPs, GCP and regulatory requirements.

Key responsibilities

• Ensure project timelines are met and manage the transfer, imaging, scanning, retention and disposition of records.
• Coordinate retrieval of records, prepare closed studies for final transfer and oversee disposal of obsolete records.
• Monitor filing accuracy, conduct imaging and scanning processes, and train staff on related procedures.
• Maintain records centre security and act as primary contact for internal and external clients.

Required profile

• Bachelor’s degree in Records Management or related field, or equivalent experience.
• Minimum four years of experience in a technical records management environment, preferably with TMF oversight.
• Strong knowledge of ICH, GCP and local regulatory requirements.
• Ability to manage multiple tasks, analyze problems and make sound decisions under pressure.

Required skills

• Records Management
• Trial Master File (TMF) oversight
• Imaging and scanning technologies
• Regulatory compliance (ICH, GCP)