TMF Associate

Job Summary

Managing the Trial Master File (TMF) content and associated processes, the full-time TMF Associate will ensure TMF completeness and inspection readiness throughout the study lifecycle while working remotely and collaborating with cross-functional teams.

Key responsibilities

• Serve as the primary TMF contact for assigned studies and ensure timely filing of documents
• Develop and maintain study-specific TMF management documents and provide training to stakeholders
• Conduct periodic quality control checks and manage TMF help desk tickets to resolve issues

Required qualifications

• College diploma/degree with 1-3 years of relevant experience or ongoing training
• Understanding of TMF organization, implementation, and archival regulations
• Ability to apply ALCOA principles in TMF oversight
• Demonstrated computer literacy and functional knowledge of Microsoft Office packages
• Strong time management and problem-solving skills