Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
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.
Responsibilities:
- 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:
- Bachelor's degree in life sciences, documentation management, or a related discipline
- Extensive experience in TMF management or clinical operations within the pharmaceutical or clinical research industry.
- Strong understanding of GCP, ICH guidelines, and global regulatory requirements related to TMF management and clinical trial documentation.
- Proven leadership skills, with experience managing and developing teams in a fast-paced, regulated environment.
- Excellent organisational and project management skills, with the ability to oversee multiple clinical studies and maintain high standards of documentation.
- Strong communication and interpersonal skills, with experience collaborating with cross-functional teams and external stakeholders.
- Proficiency in electronic TMF systems and document management tools, with a focus on maintaining regulatory compliance and audit readiness.
- Willingness to travel as required (approximately 25%)
Rewards & Benefits
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways