TMF Operations Associate

Job Summary

Serving as the primary contact for assigned studies, the full-time TMF Operations Associate will manage the Trial Master File (TMF) content and processes throughout the study lifecycle, ensuring completeness and inspection readiness while working remotely.

Key responsibilities

• Ensure TMF completeness and readiness for inspections, filing documents contemporaneously throughout the study lifecycle
• Develop study-specific TMF management documents and maintain quality control schedules for TMF completeness
• Provide mentorship and training to junior staff while participating in department meetings and discussions to improve internal systems

Required qualifications

• College diploma/degree with 3 years of relevant experience or ongoing training
• Understanding of TMF organization, implementation, and archival, including relevant regulations
• Ability to apply ALCOA principles in TMF oversight
• Demonstrated computer literacy and knowledge of Microsoft Office applications
• Strong time management and problem-solving skills