TMF Specialist All Levels

Role Overview ICON plc is a globally recognized healthcare intelligence and clinical research organization committed to advancing the future of clinical development. We are looking for a skilled TMF Specialist at any experience level to join our Chennai team in a hybrid work arrangement. In this role, you will be responsible for end-to-end document management activities supporting both client service contracts and internal business operations. Key Responsibilities - Process clinical study documents in compliance with client requirements, ICON SOPs and applicable regulatory guidelines - Liaise effectively with study project teams and TMF staff to fulfill all document management responsibilities - Maintain and organize Trial Master Files as per study, client, and regulatory requirements - Perform document receipt, review, scanning, indexing, quality control, filing, copying, and archiving activities - Provide timely status updates and reports to TMF department management as requested - Support and participate in client and ICON audits as well as document archiving initiatives - Coordinate with clients on project-related issues as directed by the Manager - Complete departmental and special projects within defined timelines per ICON SOPs Required Qualifications - 1 to 15 years of hands-on experience with Trial Master Files and clinical study documentation - Strong understanding of clinical research processes and regulatory requirements - Bachelor's degree in Life Sciences or a related field preferred - Excellent oral and written communication skills along with strong interpersonal abilities - Proven ability to work collaboratively with project teams, clients, and management Why Join Us ICON plc offers a competitive compensation package along with a comprehensive suite of benefits focused on employee well-being, work-life balance, and long-term career growth. We foster an inclusive and diverse workplace where every team member is valued and empowered to make a meaningful impact in clinical research.

- 1 to 15 years of TMF or Trial Master File experience - Strong knowledge of clinical study documentation and processes - Bachelor's degree in Life Sciences preferred - Good oral and written communication skills - Strong interpersonal and team collaboration skills - Familiarity with ICON SOPs, working practices, and applicable regulations - Ability to manage multiple tasks and meet deadlines

- Competitive salary and performance-based rewards - Annual leave entitlements as per company policy - Range of health insurance options for employee and family - Competitive retirement and savings planning offerings - Global Employee Assistance Programme via LifeWorks with 24-hour access - Life assurance coverage - Flexible country-specific benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, and subsidized travel passes