TMF Specialist II – Office with Flex | Chennai, India
Job ID: JR142500
Location: Chennai, India
Employment Type: Full-Time
Work Model: Office-Based with Flexibility
Company: ICON plc
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization providing full-service clinical development solutions to pharmaceutical, biotechnology, and medical device companies. With expertise across all phases of clinical trials, ICON ensures regulatory compliance, operational excellence, and high-quality data delivery worldwide.
Position Overview
ICON plc is seeking a TMF Specialist II to support Trial Master File (TMF) management and document control activities for global clinical trials. Based in Chennai, this office-based role with flexibility is responsible for ensuring that TMF documentation is complete, accurate, and inspection-ready in compliance with ICH-GCP, regulatory standards, and sponsor requirements.
The TMF Specialist II will collaborate with cross-functional teams to maintain document quality, regulatory compliance, and operational efficiency across client and internal ICON projects.
Experience Required
Minimum 3+ years of experience in clinical research, TMF management, or clinical document management.
Hands-on experience working with electronic Trial Master File (eTMF) systems preferred.
Key Responsibilities
Manage and maintain Trial Master File (TMF) documentation in accordance with ICH-GCP and regulatory guidelines.
Ensure completeness, accuracy, and timeliness of essential documents throughout the clinical trial lifecycle.
Perform quality control (QC) checks and reconciliation activities to ensure inspection readiness.
Support client service contracts and internal project requirements related to TMF oversight.
Collaborate with Clinical Operations, Regulatory Affairs, Data Management, and study teams for document tracking and filing.
Identify documentation gaps and drive corrective actions to maintain compliance.
Support audits and regulatory inspections by ensuring TMF documentation meets global standards.
Required Qualifications & Skills
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
Strong understanding of clinical trial documentation processes and regulatory frameworks.
Experience with eTMF platforms and document management systems.
High attention to detail with strong organizational skills.
Ability to work collaboratively in cross-functional global teams.
Excellent communication and problem-solving skills.
Core Skills & SEO Keywords
TMF Specialist Jobs India, Trial Master File Management, eTMF Careers Chennai, Clinical Document Management, ICH-GCP Compliance, CRO Jobs India, Clinical Trial Documentation, Regulatory Inspection Readiness.
Why Join ICON plc
ICON offers competitive compensation and comprehensive benefits tailored by region, 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 diversity, inclusion, and maintaining a professional workplace free from discrimination and harassment.
How to Apply
Professionals with clinical document management and TMF expertise are encouraged to apply through the official ICON careers portal.
For more global Clinical Research, TMF, and CRO job opportunities, visit ThePharmaDaily.com.
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