TMF Lead

ICON plc • Blue Bell, SD

20h • Remote

About The Position

TMF Lead- 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 TMF Lead to join our diverse and dynamic team. As a 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. Your expertise will be essential in maintaining the integrity of the TMF and supporting efficient document management throughout the trial lifecycle.

Requirements

• Bachelor's degree in a relevant field such as life sciences, nursing, or business administration; advanced degree preferred.
• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level