TMF Operations Associate

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