TMF Specialist I – Clinical Research
Location: Chennai, India (Office with Flexible Work Options)
Job Type: Full-Time
Company: ICON plc
Posted: 6 Days Ago
Job ID: JR142500
About ICON plc
ICON plc is a global leader in clinical research and healthcare intelligence, committed to delivering innovative solutions that accelerate clinical development worldwide. With a diverse and inclusive workforce, ICON fosters collaboration, innovation, and operational excellence. Our mission is to shape the future of clinical development by ensuring high-quality services and compliance across all clinical trials.
Role Overview
We are seeking a TMF Specialist I to join our dynamic clinical research team in Chennai. This role is essential for supporting Trial Master File (TMF) documentation and management, ensuring compliance with client requirements and ICON’s internal procedures.
As a TMF Specialist I, you will gain hands-on experience with TMF processes, contribute to regulatory-compliant documentation, and collaborate with cross-functional teams to maintain high-quality trial documentation.
Key Responsibilities
Develop familiarity with Trial Master File (TMF) documentation and document management workflows.
Support client services contracts and internal business requirements related to TMF management.
Maintain TMF documentation to ensure compliance with regulatory standards and ICON SOPs.
Assist in organizing, filing, and tracking trial documents to maintain inspection readiness.
Collaborate with clinical operations, data management, and regulatory teams to ensure timely and accurate documentation filing.
Contribute to continuous process improvements for TMF management.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
0–2 years of experience in clinical research, document management, or TMF operations preferred.
Strong attention to detail, organizational skills, and ability to maintain high-quality documentation.
Effective team player with excellent verbal and written communication skills.
Familiarity with regulatory compliance standards is a plus.
Why Join ICON
Global Exposure: Work with leading international clients in clinical trials across multiple therapeutic areas.
Career Development: Gain expertise in TMF management, clinical documentation, and regulatory processes with opportunities to grow into senior roles.
Inclusive Culture: Join a workplace that values diversity, equity, and inclusion.
Comprehensive Benefits: ICON offers competitive salary packages, annual leave, health insurance, retirement planning, life assurance, wellness programs, flexible benefits, and employee assistance programs.
Work-Life Balance: Flexible office options and support for your personal and professional well-being.
Apply Today
If you are detail-oriented, eager to learn, and passionate about clinical research and regulatory compliance, ICON invites you to apply for TMF Specialist I. Whether you are just starting your career or looking to expand your expertise in TMF and clinical trial documentation, this role offers excellent growth opportunities within a leading global CRO.
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