TMF Group Lead

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Group Lead for Trial Master File (TMF) Operations, you will provide oversight and leadership for TMF processes, ensuring compliance and quality in document management across clinical trials. This is a home-based role.

Key responsibilities

• Manage trial master file management activities across your area so that your team delivers to the highest standards.
• Lead and manage the TMF Operations team to ensure clinical trial documentation is handled in a timely and accurate way.
• Oversee TMF processes and workflows to ensure compliance with regulatory requirements and industry standards.
• Collaborate with cross-functional teams to support the maintenance, inspection and archival of TMF documents.
• Provide training and guidance to team members, promoting best practices in TMF management.
• Monitor performance metrics and implement improvements to enhance TMF quality and efficiency.

Required profile

• 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.
• Proven management experience and leadership skills, with the ability to manage and motivate a team.
• Willingness to travel as required (approximately 5%).
• Legal right to work in the country where the role is based.

Required skills

• Strong understanding of regulatory requirements and best practices related to TMF management.
• Excellent communication and organisational skills, with attention to detail and a commitment to quality.

What we offer

• 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.