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 Group Lead - Trial Master File (TMF) Operations at ICON, you will provide oversight and leadership for TMF processes, ensuring compliance and quality in document management across clinical trials.
Responsibilities
You will manage trial master file management activities across your area, ensuring your team delivers to the highest standards. Key responsibilities include:
- Leading and managing the TMF Operations team to ensure timely and accurate handling of clinical trial documentation.
- Overseeing TMF processes and workflows to ensure compliance with regulatory requirements and industry standards.
- Collaborating with cross-functional teams to support the maintenance, inspection, and archival of TMF documents.
- Providing training and guidance to team members, promoting best practices in TMF management.
- Monitoring performance metrics and implementing improvements to enhance TMF quality and efficiency.
Your Profile
You will have a strong background in trial master file management, with proven management experience and a commitment to quality delivery. Required qualifications and experience:
- Bachelor's degree in life sciences, information management, or a related field, or equivalent experience.
- Extensive experience in TMF operations within clinical research or the pharmaceutical industry.
- Strong understanding of regulatory requirements and best practices related to TMF management.
- Proven leadership skills with the ability to manage and motivate a team effectively.
- Excellent communication and organisational skills, with attention to detail and a commitment to quality.
- Willingness to travel as required (approximately 5%).
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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.