Senior TMF Specialist – Chennai, India
Location: Chennai, India
Job Type: Full-Time, Hybrid (Office-Based)
Department: Full Service & Corporate Support – Regulatory Document Management
Job ID: JR132671
About ICON
ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing innovative treatments and therapies. We foster an inclusive, collaborative environment that drives excellence, innovation, and patient-centered solutions.
Joining ICON means contributing to a mission that shapes the future of clinical development while working with a diverse and dynamic team.
Role Overview
We are seeking a Senior TMF Specialist to manage the Trial Master File (TMF) for clinical trials in compliance with global regulatory requirements. The role focuses on eTMF management, documentation completeness, and inspection readiness, supporting the advancement of innovative treatments and clinical research programs.
This role is ideal for candidates looking to grow their career in clinical trial documentation, regulatory compliance, and TMF management.
Key Responsibilities
TMF Management & Review
Perform comprehensive eTMF completeness checks, milestone reviews, cross-checks, and co-dependency checks.
Identify missing documents and ensure alignment with the Expected Document List (EDL).
Conduct ALCOA-E and metadata checks to maintain accuracy, compliance, and audit readiness.
Ensure assigned TMFs are inspection-ready for regulatory authorities.
Collaboration & Coordination
Work closely with study teams and TMF Leads to gather documentation requirements.
Follow up on pending action items to ensure timely resolution.
Support and conduct internal training sessions to address TMF-related queries.
Compliance & Standardization
Adhere to TMF regulations, guidelines, and industry best practices.
Follow standard SLAs and deliverables agreed with stakeholders.
Maintain robust documentation standards to support regulatory audits.
Candidate Profile
Education:
Bachelor’s degree in a scientific field (Life Sciences, Pharmacy, or related).
Advanced degrees are a plus.
Experience:
Freshers and entry-level candidates are encouraged to apply.
Previous internships or exposure to TMF processes, eTMF systems, or clinical documentation is advantageous.
Skills & Competencies:
Understanding of TMF regulations, ICH-GCP guidelines, and clinical documentation best practices.
Familiarity with electronic document management systems (e.g., Veeva Vault) is preferred.
Strong organizational, communication, and attention-to-detail skills.
Ability to work collaboratively in a cross-functional, team-oriented environment.
Why Join ICON?
Exposure to global clinical research and TMF operations.
Structured career development in clinical operations, regulatory affairs, and document management.
Competitive salary and comprehensive benefits, including:
Health insurance for you and your family.
Retirement planning options.
Life assurance and flexible country-specific benefits.
Access to the Global Employee Assistance Programme (LifeWorks) for well-being support.
Inclusive, diverse, and collaborative workplace culture.
Equal Employment Opportunity
ICON plc is committed to diversity, inclusion, and equal opportunity. All qualified candidates will receive consideration regardless of race, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations are available throughout the recruitment process for candidates with disabilities or medical conditions.
Application Guidance
If you are unsure whether you meet all the requirements, we encourage you to apply. ICON values potential, motivation, and willingness to learn, and freshers are welcome to join our team.
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