TMF Specialist II
Location: Chennai, India
Work Model: Office with Flex
Employment Type: Full-Time
Job ID: JR142500
Company: ICON plc
ThePharmaDaily.com is featuring an excellent opportunity for a TMF Specialist II with ICON plc, a globally recognized clinical research organization (CRO) specializing in healthcare intelligence and clinical development services. This role is ideal for professionals with experience in Trial Master File (TMF) management and clinical documentation within regulated environments.
Job Summary
The TMF Specialist II is responsible for maintaining, reviewing, and ensuring the completeness and compliance of Trial Master File (TMF) documentation in alignment with ICH-GCP guidelines, regulatory standards, sponsor expectations, and company SOPs. The position supports both client-sponsored clinical trials and internal operational requirements while ensuring inspection readiness.
Key Responsibilities
Manage and maintain electronic and/or paper Trial Master Files (eTMF/TMF)
Ensure TMF documentation complies with ICH-GCP, regulatory authorities, and sponsor requirements
Perform quality control checks on trial documentation
Support audit and inspection readiness activities
Track essential documents across the clinical trial lifecycle
Collaborate with Clinical Operations, Regulatory Affairs, and Quality teams
Identify and resolve documentation gaps and discrepancies
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related discipline
Minimum 3+ years of experience in TMF management, clinical documentation, or clinical research operations
Strong understanding of ICH-GCP and regulatory documentation standards
Experience working with electronic TMF (eTMF) systems preferred
High attention to detail and strong organizational skills
Effective written and verbal communication skills
Ability to work in cross-functional and global team environments
Core Skills
Clinical trial documentation management
Regulatory compliance and quality assurance
Inspection and audit preparation
Process improvement and documentation control
Time management and analytical skills
Compensation and Benefits
ICON offers a competitive salary package along with country-specific benefits designed to support employee well-being and work-life balance. Benefits may include:
Annual leave entitlements
Health insurance coverage
Retirement planning programs
Global Employee Assistance Programme (TELUS Health)
Life assurance
Flexible optional benefits such as childcare support, wellness initiatives, gym memberships, and travel subsidies
Equal Opportunity Statement
ICON is committed to building an inclusive and diverse workplace. All qualified applicants will receive equal consideration for employment without discrimination based on protected characteristics. Reasonable accommodations are available for candidates requiring support during the application or employment process.
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