Senior TMF Specialist – Office with Flex | Chennai, India
Job ID: JR142071
Location: Chennai, India
Employment Type: Full-Time
Work Model: Office-Based with Flexibility
Application Deadline: February 27, 2026
Company: ICON plc
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization delivering comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies. With a strong global footprint, ICON supports regulatory-compliant clinical trials across all phases, ensuring quality, data integrity, and inspection readiness.
Position Overview
ICON plc is hiring a Senior TMF Specialist to oversee Trial Master File (TMF) management and ensure inspection readiness for global clinical trials. This Chennai-based role requires advanced expertise in eTMF systems, periodic reviews, regulatory compliance, and document completeness assessments.
The Senior TMF Specialist will play a critical role in maintaining high-quality TMF documentation aligned with ICH-GCP guidelines and global regulatory standards while collaborating closely with study teams and TMF Leads.
Experience Required
Minimum 7 years of experience in TMF management and periodic review activities within clinical research.
At least 2–3 years of experience in identifying and resolving missing TMF documents.
Hands-on experience with Veeva Vault eTMF system preferred.
Key Responsibilities
Perform comprehensive eTMF completeness checks, periodic reviews, and milestone-based assessments.
Conduct cross-checks, co-dependency checks, and identify missing or incomplete documentation within Veeva Vault.
Ensure eTMF is inspection-ready for allocated studies at all times.
Maintain and update the Expected Document List (EDL) as required.
Conduct ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) and metadata quality checks.
Collaborate with study teams and TMF Leads to gather review requirements and close action items.
Follow up with stakeholders to resolve documentation gaps within defined SLAs.
Provide training and guidance to internal teams on TMF processes and compliance standards.
Required Qualifications & Skills
Bachelor’s degree in Life Sciences, Pharmacy, or related scientific discipline; advanced degree preferred.
Strong understanding of TMF regulations, ICH-GCP guidelines, and global inspection readiness requirements.
Proficiency in electronic document management systems (eDMS) and eTMF platforms, particularly Veeva Vault.
Advanced knowledge of TMF document classification and regulatory documentation standards.
Excellent organizational skills with high attention to detail.
Strong communication and stakeholder management capabilities.
Core Skills & SEO Keywords
Senior TMF Specialist Jobs India, eTMF Veeva Vault Careers, Trial Master File Review, Clinical Document Management Chennai, TMF Inspection Readiness, ICH-GCP Compliance, CRO Jobs India, Regulatory Documentation Specialist.
Why Join ICON plc
ICON offers competitive compensation and comprehensive country-specific benefits designed to support employee well-being and career growth, including:
Annual leave entitlements
Health insurance coverage
Retirement planning programs
Life assurance
Global Employee Assistance Programme (TELUS Health)
Flexible optional employee benefits
ICON is committed to maintaining a diverse, inclusive, and discrimination-free workplace.
How to Apply
Experienced TMF professionals with strong inspection readiness and Veeva Vault expertise are encouraged to apply through the official ICON careers portal before the application deadline.
For more global Clinical Research, TMF, and Regulatory Documentation job opportunities, visit ThePharmaDaily.com.
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