TMF Group Lead

ICON plc

Poland Warsaw Onsite Medical Regulatory Affairs

About this role

TMF Group Lead - Poland or Bulgaria - Remote

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 Group Lead - TMF Operations to join our diverse and dynamic team. As the Group Lead of TMF (Trial Master File) Operations at ICON, you will provide oversight and leadership for TMF processes, ensuring compliance and quality in document management across clinical trials. Your expertise will be key in maintaining TMF integrity and supporting ICON’s commitment to excellence in clinical research.

What You Will Be Doing:

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:

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 organizational skills, with attention to detail and a commitment to quality.

#LI-DK2

#LI-Remote

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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