Senior TMF Lead
Core
Operational leadership for the Trial Master File (TMF) across a global pharmaceutical portfolio, ensuring regulatory compliance and inspection readiness.
Role type
Senior Manager, TMF Operations Lead
Builds
Defensible clinical trial records and operational standards for regulatory submissions
Domain
Pharmaceutical clinical trials / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
TMF governance and process management, vendor oversight, inspection and audit readiness, KPI and metrics management, people leadership and team development, eTMF platform expertise
Preferred skills
Clinical research experience, regulatory landscape knowledge (ICH GCP, FDA, EU), change management, procedural documentation
Technologies
Veeva Vault, eTMF platforms, MS Office suite
Responsibilities
Develop and implement TMF oversight processes, oversee TMF technologies and continuous improvement, manage External Service Provider performance, support internal and external inspections, establish and report TMF metrics, lead and develop TMF staff
Seniority
Senior Manager, hands-on leadership
