Trial Master File Operations Manager

Manager, TMF Operations

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 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 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 organizational 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%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply