PHARMAFull-time
Senior TMF Specialist
CHENNAI (IN)HYBRIDPOSTED: 8/18/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Manage, maintain, and oversee the Trial Master File (TMF) across assigned global clinical trials throughout the complete study lifecycle.
Ensure end-to-end completeness, accuracy, and high quality of all essential clinical trial documentation in accordance with GCP guidelines and study-specific milestones.
Partner closely with cross-functional study teams to ensure timely collection, processing, QC, and filing of regulatory and essential documents.
Perform routine TMF quality reviews, audits, and inspection readiness checks to ensure compliance with global regulatory authority standards and sponsor requirements.
Provide expert guidance, operational support, and best practice advisory on TMF-related matters to internal and external stakeholders.
Technical & Domain Standards
Strong command of GCP, ICH guidelines, and global regulatory requirements governing clinical trial documentation.
Deep practical knowledge of the DIA TMF Reference Model and electronic Trial Master File (eTMF) systems.
Proven proficiency in electronic document management systems (EDMS) and specialized eTMF software platforms.
Leadership & Collaboration
Serve as a senior subject matter resource, providing mentorship and operational coaching to junior TMF team members.
Collaborate effectively across study managers, clinical operations teams, investigators, and quality assurance personnel to resolve document discrepancies and audit findings.
Benefits & Total Rewards
Competitive base salary with performance-linked annual incentives.
Comprehensive health and wellbeing programs, including medical, dental, and vision coverage.
Retirement and pension plans along with life assurance and disability coverage.
Structured learning and career development opportunities via dedicated corporate pathways.
REQUIRED VERIFIED SKILLS
TMF Management
eTMF
DIA TMF Reference Model
Good Clinical Practice (GCP)
Document QC
Inspection Readiness
Regulatory Compliance
Clinical Documentation
COMPENSATION & REWARDS
₹6.5L - 12.0L per annum
ORGANIZATION CONTEXT & CULTURE
ICON plc is a global provider of outsourced drug development and commercialization services to pharmaceutical, biotechnology, medical device, and government organizations. The company specializes in a broad range of clinical research services, from Phase I-IV studies to consulting and data solutions. ICON helps its clients accelerate the development of drugs and devices through comprehensive scientific and operational expertise.
TEAM SIZE: 41,100+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
RECOMMENDED TRAINING
1/5
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