TMF Specialist II
Location: Chennai, Tamil Nadu, India
Work Model: Office-Based (Flexible)
Employment Type: Full-Time
Experience Required: Minimum 3+ Years in Clinical Research or Document Management
Job Requisition ID: JR142500
About the Company
ICON plc is a global healthcare intelligence and clinical research organization providing comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies. ICON supports global regulatory compliance, clinical trial excellence, and innovation across all phases of research.
Role Overview
The TMF Specialist II will support Trial Master File (TMF) operations and clinical document management activities for global clinical trials. This role focuses on maintaining compliant, accurate, and inspection-ready TMF documentation aligned with ICH-GCP guidelines, sponsor requirements, and internal SOPs.
This position is ideal for professionals with foundational TMF or clinical documentation experience seeking to advance within a CRO environment and strengthen expertise in electronic TMF systems and regulatory compliance.
Key Responsibilities
TMF Documentation & Compliance
Support the maintenance and organization of Trial Master File (TMF) documentation
Ensure documents are filed accurately and in a timely manner within electronic TMF systems
Verify documentation compliance with client contracts and ICON procedures
Assist in ensuring inspection readiness and regulatory alignment
Operational Support & Process Adherence
Contribute to client service deliverables and internal TMF-related projects
Follow defined Standard Operating Procedures (SOPs) and quality standards
Monitor document completeness and support document tracking activities
Escalate discrepancies or missing documentation to appropriate stakeholders
Cross-Functional Collaboration
Work closely with study teams, clinical operations, and document management teams
Ensure timely communication regarding document requirements and updates
Support continuous process improvements within TMF operations
Educational Qualifications
Bachelor’s Degree in Life Sciences, Pharmacy, Clinical Research, or related field (Required)
Experience Required
Minimum 3+ years of experience in clinical research, clinical documentation, or TMF management
Exposure to Trial Master File (TMF) processes and regulatory documentation standards
Experience working in a CRO, pharmaceutical, or clinical research organization preferred
Technical Skills & Competencies
Working knowledge of ICH-GCP guidelines and TMF best practices
Familiarity with electronic document management systems (eTMF platforms preferred)
Strong attention to detail and documentation accuracy
Effective organizational and time-management skills
Strong written and verbal communication skills
Ability to collaborate effectively within cross-functional teams
Why Consider This Opportunity
This role provides exposure to global clinical trial documentation processes and regulatory compliance standards within a leading CRO environment. It offers structured career progression in TMF operations, clinical documentation management, and inspection readiness support for international studies.
Equal Opportunity Statement
ICON plc is an equal opportunity employer committed to creating an inclusive and accessible workplace. All qualified applicants will receive consideration without regard to protected characteristics under applicable laws.
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