Sr. eTMF Specialist

ICON plc • Raleigh, NC

2d

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization. As a Sr. eTMF Specialist, you will ensure the accuracy and completeness of the Trial Master File (TMF) throughout the clinical trial process. This role involves contributing to trial master file management activities, taking responsibility for your deliverables, and working collaboratively within an inclusive environment that drives innovation and excellence. The company is proud to foster an inclusive environment and welcomes individuals to join its mission to shape the future of clinical development.

Requirements

• Bachelor's degree in life sciences, healthcare, or a related field.
• 2+ years of experience in clinical trial operations or document management, with a focus on Trial Master File processes.
• Strong attention to detail and organizational skills, with a commitment to maintaining high-quality standards.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams.
• Proficiency in electronic document management systems and an understanding of regulatory requirements related to TMF.
• Willingness to travel as required (approximately 5%).

Responsibilities

• Managing the quality and integrity of the TMF by ensuring timely and accurate document uploads and metadata management.
• Collaborating with cross-functional teams to identify and resolve discrepancies in TMF documentation.
• Conducting regular audits of the TMF to ensure compliance with regulatory requirements and internal procedures.
• Providing training and support to team members on TMF best practices and document management systems.
• Generating reports and metrics to track TMF status and provide insights for continuous improvement.

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: Senior