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 TMF Lead at ICON, you will be responsible for overseeing the Trial Master File (TMF) management processes, ensuring compliance with regulatory requirements and best practices in clinical trials.
Responsibilities:
- Leading the setup, maintenance, and oversight of the TMF in compliance with regulatory standards and internal policies.
- Collaborating with cross-functional teams to ensure timely and accurate documentation within the TMF.
- Conducting regular TMF quality checks and audits to identify and resolve discrepancies or issues.
- Providing training and support to team members on TMF processes and best practices.
- Establishing and implementing strategies for continuous improvement in TMF management and documentation practices.
Requirements:
- Bachelor's degree in a relevant field such as life sciences, nursing, or business administration; advanced degree preferred.
- Proven experience in TMF management or clinical trial document management, preferably within the healthcare or clinical research industry.
- Strong understanding of regulatory requirements and industry standards related to TMF and clinical documentation.
- Excellent organisational skills and attention to detail, ensuring compliance and accuracy in TMF management.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
- A commitment to promoting equity and inclusion in all aspects of TMF management.
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