Manager - TMF Operations

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
• MBA or B.Sc or BBA