TMF Specialist (All Levels)

Roles & Responsibilities
• Manage clinical study documents in line with client, regulatory, and ICON requirements
• Perform document receipt, review, quality checks, scanning, indexing, filing, and archiving in the Trial Master File (TMF)
• Ensure continuous compliance with ICON SOPs, work procedures, and applicable regulatory guidelines
• Collaborate with study teams, clients, and internal ICON departments to support study deliverables
• Participate in internal and external audits and support inspection readiness activities
• Prepare and maintain TMF status reports and tracking logs
• Identify gaps or issues in TMF documentation and support corrective actions
• Participate in training programs to enhance TMF and clinical research knowledge
• Support special projects and additional responsibilities as assigned by the Manager

Qualification
• B.Pharm / M.Pharm / Pharm.D / BSc / MSc in Life Sciences or related disciplines

Experience
• 1-15 years of experience in TMF management or clinical document management
• Strong understanding of clinical trial documentation and TMF processes

Skills
• Strong oral and written communication skills
• Excellent attention to detail and document accuracy
• Good interpersonal and stakeholder coordination skills
• Strong organizational and time management abilities
• Working knowledge of clinical trial regulations and documentation standards

About the Company
ICON plc is a global leader in clinical research and healthcare intelligence, committed to advancing clinical development through innovation,

partnership, and integrity, while fostering an inclusive work environment focused on improving patient lives worldwide.