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
TMF Operations Associate
Builds
Controlled electronic file repositories for clinical studies
Domain
Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
TMF organization and implementation, ALCOA principles, document management, quality control scheduling, stakeholder communication, time management, problem-solving
Preferred skills
Knowledge of relevant clinical regulations, Microsoft Office proficiency, system development assistance
Technologies
Microsoft Office packages, electronic file repository systems
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; mentor junior staff.
Seniority
Junior to Mid-level, hands-on IC