TMF Quality Project Manager
Core
Liaison between Records Management and user departments to manage Trial Master Files (TMF) across clinical research projects, ensuring compliance with GCP and regulatory requirements while meeting quality and timeline metrics.
Role type
Senior IC Records Management Project Manager (Clinical Research)
Builds
Closed studies, compliant TMF records, and efficient records storage/disposition workflows for life sciences clients.
Domain
Clinical Research / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
TMF oversight and reconciliation, GCP and ICH regulatory knowledge, records lifecycle management (transfer, imaging, scanning, retention, disposition), project timeline management, team leadership, strategic planning for records management
Preferred skills
Experience with IQVIA or customer file plans, technology applications for records management, problem analysis and solution development
Technologies
Imaging and scanning systems, records management software
Responsibilities
Coordinate retrieval of records and prepare closed studies for transfer; monitor filing accuracy and compliance with SOPs; conduct and manage imaging/scanning processes; train staff on records management procedures; oversee disposal of obsolete records; interface with internal departments to support retrieval projects; assist management with strategic goals and resource projections for records management projects
Seniority
Senior, hands-on IC with team leadership capabilities