Manager, TMF Operations
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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 Will Do:
You will oversee trial master file management workstreams, ensuring deliverables meet quality and timeline expectations.
Key responsibilities include:
- Managing the TMF Operations team responsible for maintaining the Trial Master File (TMF) across multiple clinical studies, ensuring compliance with GCP and regulatory requirements.
- 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, to ensure TMF completeness and readiness for audits and inspections.
- Developing and implementing TMF management strategies, policies, and procedures to improve efficiency and ensure adherence to industry standards.
- Monitoring TMF quality metrics, identifying areas for improvement, and driving continuous process enhancements.
- Providing leadership and training to TMF staff, fostering a culture of quality and compliance within the team.
- Ensuring readiness of TMF for regulatory audits and client inspections, addressing any findings or gaps in documentation as needed.
Your Profile:
You will have solid trial master file management experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
- Bachelor's degree in life sciences, documentation manage
📌 Manager - TMF Operations (Chennai)
🏢 IRE
📍 Chennai