Roles & Responsibilities:
• Manage end-to-end TMF and document management operations in compliance with ICON SOPs, client requirements, and regulatory guidelines
• Lead and mentor 20–30 TMF professionals, ensuring high performance and quality delivery
• Coordinate TMF activities across multiple studies and clients
• Generate and present TMF status reports for internal stakeholders and clients
• Drive process improvement initiatives to enhance efficiency and quality
• Ensure TMF inspection readiness and participate in internal and external audits
• Oversee TMF archiving activities and study close-out documentation
• Liaise with clinical study teams, training departments, and clients
• Manage quality control, tracking, and compliance metrics
• Support departmental and cross-functional projects as assigned
Qualification:
• Bachelor’s degree in Science, Medicine, Pharmacy, Life Sciences, or equivalent
• Strong understanding of clinical study start-up, maintenance, and close-out activities
Experience:
• 12+ years of experience in TMF Operations within clinical research or CRO environments
• 3+ years of people management experience managing large teams (20–30 members)
Skills:
• Excellent organizational, communication, and stakeholder management skills
• Proven ability to manage multiple projects and global clients
• Strong analytical, problem-solving, and conflict management skills
• Willingness to travel up to 25% (domestic/international)
About the Organisation:
ICON plc is a global leader in healthcare intelligence and clinical research, known for its strong culture of Accountability, Collaboration, Partnership, and Integrity. ICON provides professionals the opportunity to work on global clinical trials, shaping the future of drug development while delivering high-quality solutions to clients worldwide.
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