Sr Director, TMF Operations

Sr Director - TMF, Operations

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 Senior Director, TMF Operations to join our diverse and dynamic team. As a Senior Director, TMF Operations at ICON, you will play a pivotal role in overseeing the management and optimization of Trial Master File (TMF) operations, ensuring compliance with regulatory standards, and driving efficiency in clinical trial processes.

What you will be doing

• Drive and oversee the TMF Operations team, providing strategic direction and guidance to ensure timely and accurate management of trial documentation.
• To lead and manage in innovative technology projects such as RPA (Robotic process automations), AI (artificial intelligence), Machine learning, system automation and integration
• Manage Global eTMF vendors, Global Strategic Clients, and sponsors for eTMF delivery.
• Develop and implement best practices for TMF management, including document collection, review, and archival processes.
• Collaborate with cross-functional teams to ensure alignment of TMF processes with study protocols and regulatory requirements.
• Drive continuous improvement initiatives to enhance TMF quality, completeness, and inspection readiness.
• Monitor TMF metrics and performance indicators to identify areas for improvement and implement corrective actions as needed.

Your profile

• Bachelor's degree in a related field; advanced degree preferred.

• Minimum of 18+ years of experience in clinical operations, with at least 10+ years of experience in TMF management.

• Proven leadership experience, with the ability to effectively manage and develop teams.

• In-depth knowledge of regulatory requirements governing TMF management, including ICH-GCP guidelines.

• Strong project management skills, with the ability to prioritize and manage multiple tasks and projects simultaneously.

• Excellent communication skills, with the ability to work effectively with internal and external stakeholders.

• Demonstrated ability to drive process improvements and implement best practices in TMF operations.

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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