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Senior Tmf Specialist

7+ years
Not Disclosed
10 Oct. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior TMF Specialist – ICON plc

Location: Chennai, India
Job ID: JR132671
Portfolio: Full Service & Corporate Support – Regulatory Document Management
Work Type: Hybrid / Office-Based


Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, advancing the future of clinical development.


Role Overview

The Senior TMF Specialist is responsible for managing the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements, and supporting the inspection readiness of allocated studies. The role involves document review, collaboration with study teams, and providing guidance to internal staff on TMF processes.


Key Responsibilities

  • Perform comprehensive eTMF completeness checks, periodic or milestone reviews, including cross checks and co-dependency checks to identify missing documents in Veeva Vault.

  • Ensure eTMF is inspection-ready for assigned studies.

  • Conduct completeness checks and update the Expected Document List (EDL) as required.

  • Identify missing documents and ensure ALCOA-E and metadata compliance.

  • Collaborate with study teams and TMF Leads to collect initial requirements for review.

  • Follow up with study teams to close action items.

  • Conduct training for internal teams and address team queries.

  • Follow standard SLAs and ensure deliverables meet agreements with stakeholders.


Required Education & Skills

  • Bachelor’s degree in a scientific or related field; advanced degree preferred.

  • Minimum 7 years of experience in TMF and periodic review.

  • 2–3 years’ experience identifying missing documents.

  • Experience with Veeva Vault and strong Excel skills are advantageous.

  • Strong understanding of TMF regulations, guidelines, and best practices.

  • Proficiency in electronic document management systems and TMF software.

  • Excellent organizational, communication, and attention to detail skills.


Benefits

ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:

  • Annual leave entitlements

  • Health insurance options for employees and families

  • Competitive retirement planning offerings

  • Global Employee Assistance Programme (LifeWorks, 24/7 access to specialized professionals)

  • Life assurance

  • Flexible, country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, health assessments, etc.)

More details: ICON Careers Benefits


Diversity & Inclusion

ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Reasonable accommodations are available: Request here


Application Encouragement

Even if you don’t meet all requirements, you are encouraged to apply – you may be exactly what ICON is looking for.