TMF Operations Manager

Hybrid office based - Mexico city

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Manager, TMF Operations to join our diverse and dynamic team. As a Manager of TMF Operations at ICON, you will oversee the management, maintenance, and compliance of the Trial Master File (TMF) for clinical research studies. You will lead a team responsible for ensuring that all TMF documentation is accurate, complete, and meets regulatory requirements, playing a critical role in supporting the successful execution of clinical trials.

What You Will Be Doing:

• 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:

• Bachelor’s degree in life sciences, clinical research, or a related field. Advanced degree or certification in clinical operations or document management is a plus.
• 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.

What ICON can offer you:

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

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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