[Hiring] TMF Lead @ICON plc

Role Description

As a Trial Master File (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.

• You will oversee trial master file management workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• 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.

Qualifications

• Bachelor's degree in life sciences, documentation management, or a related discipline.
• 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 organizational 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.
• Willingness to travel as required (approximately 5%).

Requirements

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

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.
• Benefits may vary depending on role and location.

Company 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 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.