Manager, TMF Operations
Location: Chennai, India (Office-Based)
Job Reference: JR141753
Department: Regulatory Document Management
Company: ICON plc
Employment Type: Full-Time
About ICON plc
ICON plc is a globally recognized Clinical Research Organization (CRO) delivering healthcare intelligence and full-service clinical development solutions. With operations worldwide, ICON partners with biopharmaceutical companies to advance drug development and improve patient outcomes.
ICON operates with a culture built on Accountability, Collaboration, Partnership, and Integrity, making it a preferred global partner in clinical research and regulatory services.
Job Overview: Manager, TMF Operations
ICON is seeking an experienced Manager – Trial Master File (TMF) Operations to lead regulatory document management functions in Chennai. This is a senior-level leadership role responsible for overseeing TMF lifecycle management, ensuring regulatory compliance, managing large teams, and driving operational excellence across multiple global clinical trials.
The ideal candidate will bring deep expertise in TMF operations, clinical study start-up processes, regulatory documentation standards, and team leadership within a CRO or pharmaceutical environment.
Key Responsibilities
TMF Operations & Regulatory Compliance
Lead and manage Trial Master File (TMF) operations in compliance with ICH-GCP, regulatory guidelines, and company SOPs.
Oversee document receipt, review, indexing, quality control, filing, archiving, and tracking processes.
Ensure inspection readiness and support internal and external audits.
Coordinate study file archiving activities and ensure regulatory adherence.
Develop and implement study-specific documentation procedures.
Team Leadership & People Management
Manage, mentor, and supervise a team of 20–30 TMF professionals.
Drive performance management, training compliance, and career development.
Collaborate with Corporate Training teams to ensure regulatory training standards are met.
Foster a culture of continuous process improvement and operational efficiency.
Client & Stakeholder Management
Liaise with sponsors, study teams, and cross-functional departments.
Manage multiple clients and projects simultaneously.
Provide TMF status reporting and performance metrics to internal stakeholders and clients.
Address quality issues, escalation points, and timeline risks proactively.
Process Improvement & Operational Excellence
Evaluate departmental workflows for efficiency and compliance gaps.
Recommend and implement process enhancements aligned with regulatory standards.
Ensure document management systems meet global regulatory expectations.
Support strategic initiatives and departmental projects as assigned.
Travel Requirement
Up to 25% domestic and/or international travel may be required.
Required Experience
Minimum 12+ years of experience in TMF Operations within clinical research, CRO, or pharmaceutical organizations.
Strong understanding of clinical study start-up processes and regulatory documentation requirements.
At least 3+ years of people management experience, managing teams of 20–30 members.
Proven experience handling multi-study and multi-client TMF portfolios.
Experience participating in regulatory inspections and sponsor audits.
Educational Qualifications
Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or a related scientific discipline.
Equivalent professional experience in clinical document management may be considered.
Required Skills & Competencies
Advanced knowledge of ICH-GCP, regulatory frameworks, and TMF standards.
Strong leadership and team development capabilities.
Excellent organizational and multitasking skills.
High attention to detail and quality-driven mindset.
Strong written and verbal communication skills in English.
Client-focused approach with strong stakeholder management skills.
Critical thinking, conflict resolution, and problem-solving abilities.
Proficiency in document management systems and MS Office applications.
Compensation & Benefits
ICON offers competitive compensation packages benchmarked against industry standards. Benefits may include:
Performance-based annual bonuses
Comprehensive health insurance plans
Retirement and life assurance benefits
Paid annual leave
Global Employee Assistance Program (EAP)
Flexible, country-specific benefit programs supporting work-life balance
Benefits vary by location and are designed to support employee well-being and long-term career growth.
Equal Opportunity Statement
ICON plc is an equal opportunity employer committed to diversity, inclusion, and a workplace free from discrimination and harassment. All qualified applicants will receive consideration without regard to race, religion, gender, sexual orientation, national origin, disability, or veteran status.
Reasonable accommodations are available for applicants with medical conditions or disabilities during the recruitment process.
Why Apply Through ThePharmaDaily.com?
ThePharmaDaily.com connects global life sciences professionals with leading CROs, pharmaceutical companies, biotech organizations, and regulatory employers worldwide. Apply today to advance your leadership career in clinical trial document management and regulatory operations.
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