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

• Bachelors 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:

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. Were 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.

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