TMF Associate
Core
Manage Trial Master File (TMF) content and processes throughout the clinical study lifecycle, ensuring files are complete and inspection-ready.
Role type
Clinical Trial Operations Associate (TMF Management)
Builds
Controlled electronic file repositories for clinical studies
Domain
Clinical Research / Life Sciences
Required skills
TMF organization and archival, ALCOA principles, document management, quality control scheduling, stakeholder communication, time management, problem-solving
Preferred skills
Microsoft Office proficiency, database management, training delivery
Technologies
Microsoft Office, electronic file repositories
Responsibilities
Serve as primary TMF contact for assigned studies; ensure TMF completeness and contemporaneous filing; create study-specific TMF management documents; maintain quality control schedules and perform periodic inventories; review and communicate incomplete documents to study teams; reconcile expected document lists; prioritize and resolve TMF help desk tickets; provide TMF training to stakeholders; file and retrieve TMF documents; complete routine administrative tasks; assist in internal system development; mentor junior staff.
Seniority
Mid-level, hands-on IC
