Manager, TMF Operations
Location: Bangalore, India
Work Model: Office with Flex (Office-Based)
Employment Type: Full-Time
Job ID: JR141753
Application Deadline: February 20, 2026
Company: ICON plc
ThePharmaDaily.com is featuring a senior leadership opportunity for a Manager, TMF Operations with ICON plc, a globally recognized Clinical Research Organization (CRO) specializing in healthcare intelligence and end-to-end clinical development solutions. This role is ideal for experienced TMF and document management professionals with strong people management expertise and deep knowledge of clinical trial documentation processes.
Job Overview
The Manager, TMF Operations is responsible for leading document management and Trial Master File (TMF) operational activities across multiple clinical studies and clients. This position ensures regulatory compliance, inspection readiness, operational efficiency, and high-quality service delivery aligned with ICH-GCP, global regulatory standards, and sponsor requirements.
The role requires strategic oversight, process improvement leadership, stakeholder engagement, and management of large TMF teams within a dynamic global clinical research environment.
Key Responsibilities
Lead and manage TMF and document management operations for internal and client-sponsored clinical trials
Oversee document receipt, review, scanning, indexing, quality control, filing, tracking, and archiving activities
Ensure TMF documentation complies with ICON SOPs, client requirements, and global regulatory guidelines
Coordinate Document Management staff activities across multiple projects and clients
Manage status reporting for stakeholders and ensure SLA adherence
Supervise quality control activities and ensure inspection readiness
Develop and implement study-specific procedures and new business processes
Drive continuous process improvement initiatives within TMF operations
Manage document archiving and storage in compliance with regulatory requirements
Participate in client audits and regulatory inspections
Liaise with study teams, clients, and internal departments to resolve operational issues
Ensure adequate document tracking, supply management, and storage maintenance
Travel domestically or internationally as required (up to 25%)
Leadership and People Management
Manage and mentor a team of 20–30 TMF professionals
Oversee staff training and collaborate with Corporate Training teams to ensure compliance with training requirements
Address quality issues, project timelines, and team development needs
Foster a high-performance culture aligned with ICON’s core values of Accountability, Collaboration, Partnership, and Integrity
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Biotechnology, or related scientific field (or equivalent experience)
Minimum 12+ years of experience in TMF operations and clinical study documentation
Strong understanding of clinical study start-up requirements and lifecycle documentation management
Minimum 3+ years of people management experience managing teams of 20–30 members (mandatory)
Extensive knowledge of ICH-GCP guidelines and global regulatory requirements
Proven experience in managing multiple clients and complex projects
Strong expertise in document management systems and electronic TMF platforms
Excellent organizational, analytical, and problem-solving skills
Strong written and verbal communication skills in English
Customer-focused mindset with strong stakeholder management capabilities
Core Competencies
TMF lifecycle management and inspection readiness
Regulatory compliance and quality assurance
Operational leadership and team development
Process optimization and continuous improvement
Audit and risk management
Compensation and Benefits
ICON offers a competitive compensation structure benchmarked against industry standards. Performance-based annual bonuses reflect both organizational and individual achievement.
Employee benefits may include:
Annual leave entitlements
Comprehensive health insurance plans
Retirement planning programs
Life assurance coverage
Global Employee Assistance Programme (TELUS Health)
Flexible country-specific benefits including wellness programs, childcare support, and subsidized services
Equal Opportunity Statement
ICON is an equal opportunity and inclusive employer committed to maintaining a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of protected characteristics. Reasonable accommodations are available throughout the recruitment and employment process.
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