Manager – TMF Operations
Company: ICON plc
Location: Chennai, India (Office with Flex)
Employment Type: Full-Time
Experience Required: 8–12 Years (Estimated based on the leadership responsibilities and extensive TMF management experience required.)
Salary Package
Expected CTC: ₹20 LPA – ₹35 LPA (Estimated market range based on experience, leadership responsibilities, and organization. Actual salary may vary.)
Job Summary
ICON is seeking an experienced Manager – TMF Operations to lead Trial Master File (TMF) management across multiple clinical studies. The role is responsible for ensuring TMF quality, completeness, compliance, and inspection readiness while leading a team of TMF professionals and collaborating with cross-functional stakeholders to support successful clinical trial execution.
Key Responsibilities
Lead and manage the TMF Operations team responsible for maintaining Trial Master Files across multiple clinical studies.
Ensure TMF documentation complies with ICH-GCP, regulatory requirements, and company quality standards.
Oversee the collection, review, filing, and maintenance of essential clinical trial documents throughout the study lifecycle.
Monitor TMF completeness, quality, and timeliness to ensure continuous inspection readiness.
Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Writing, and other cross-functional teams.
Develop and implement TMF management strategies, policies, SOPs, and best practices to improve operational efficiency.
Monitor TMF quality metrics, identify compliance gaps, and drive continuous process improvements.
Prepare and maintain TMFs for regulatory inspections, sponsor audits, and client reviews.
Address audit findings and implement corrective and preventive actions (CAPA) related to TMF documentation.
Provide leadership, coaching, mentoring, and performance management to TMF Operations staff.
Support project planning, workload management, and resource allocation across multiple studies.
Ensure adherence to project timelines, documentation standards, and regulatory expectations.
Travel as required (approximately 25%) to support business needs.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Documentation Management, or a related discipline.
8–12 years of experience in Trial Master File (TMF) Management, Clinical Operations, or Clinical Documentation within the pharmaceutical, biotechnology, or CRO industry.
Demonstrated experience leading TMF teams in a regulated clinical research environment.
Strong knowledge of global TMF requirements and clinical trial documentation standards.
Required Skills
Expertise in Trial Master File (TMF) management and clinical documentation.
Strong understanding of ICH-GCP, TMF Reference Model, and global regulatory requirements.
Experience with electronic TMF (eTMF) systems and document management platforms.
Leadership and people management skills with experience developing high-performing teams.
Strong project management and organizational skills.
Experience preparing TMFs for regulatory inspections and sponsor audits.
Excellent communication, stakeholder management, and cross-functional collaboration abilities.
Strong analytical and problem-solving skills.
Ability to manage multiple studies and competing priorities in a fast-paced environment.
Preferred Skills
Experience with leading eTMF platforms such as Veeva Vault eTMF, Phlexglobal, Wingspan, or similar systems.
Knowledge of TMF quality metrics, compliance monitoring, and CAPA management.
Experience supporting global clinical trials across multiple therapeutic areas.
Familiarity with regulatory authority inspections (FDA, EMA, MHRA, PMDA, etc.).
Experience driving process improvement initiatives and operational excellence.
Ability to mentor and develop TMF professionals while fostering a culture of quality and compliance.
Employee Benefits
Competitive base salary with performance-based incentives.
Comprehensive medical, dental, and vision insurance (where applicable).
Retirement and pension plans.
Life insurance and disability coverage.
Employee Assistance Program (EAP).
Health and wellbeing initiatives.
Structured learning and leadership development programs.
Flexible office-based work environment.
Opportunities to work on global clinical trials within a leading Clinical Research Organization (CRO).
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