Manager - TMF Operations
ChennaiFull-timeMid levelPosted 3 weeks ago
Mid-level operations role at ICON India Clinical - in Chennai. Needs an MBA, B.Sc or BBA.
About the role
As a Manager, Trial Master File (TMF) Operations at ICON, you will oversee the management, maintenance, and compliance of the Trial Master File (TMF) for clinical research studies.
What you'll do
- Oversee trial master file management workstreams, ensuring deliverables meet quality and timeline expectations
- Managing the TMF Operations team responsible for maintaining the Trial Master File (TMF) across multiple clinical studies
- Overseeing the collection, review, and filing of essential documents, ensuring timely and accurate updates to the TMF throughout the clinical trial lifecycle
- Collaborating with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance
- Developing and implementing TMF management strategies, policies, and procedures to improve efficiency and ensure adherence to industry standards
What you need
- Documentation
- Clinical research
- GCP
- Learning and development
- Regulatory affairs