Manager – TMF Operations | ICON plc | Bangalore, India
Location: Bangalore, India
Work Model: Office with Flex (Hybrid)
Employment Type: Full-Time
Experience Required: 12+ years in TMF/Clinical Operations, including 3+ years in people management
Application Deadline: February 20, 2026
Job Requisition ID: JR141753
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research. Our mission is to advance patient care and shape the future of clinical development. We foster an inclusive and dynamic environment where innovation, collaboration, and excellence drive meaningful impact for clients, patients, and employees.
Our culture, guided by Accountability, Collaboration, Partnership, and Integrity, empowers teams to deliver high-quality outcomes and ensures ICON remains the partner of choice for clinical development worldwide.
Role Overview
The Manager – TMF Operations will lead Trial Master File (TMF) operations for clinical studies, ensuring compliance with regulatory requirements, client expectations, and ICON standard operating procedures. This role focuses on process optimization, staff management, and maintaining high-quality document management practices across multiple clients and projects.
The ideal candidate is a strategic leader with deep experience in TMF operations, clinical study start-up processes, and team management.
Key Responsibilities
Lead, mentor, and manage a team of 20–30 TMF staff, fostering a culture of high performance, accountability, and continuous improvement
Oversee TMF operations including document receipt, review, scanning, indexing, QC checks, filing, archiving, and client deliverables
Develop and implement study-specific TMF procedures and ensure adherence to ICON SOPs, WPs, and regulatory standards
Generate TMF status reports for clients and internal stakeholders; maintain accurate activity and performance tracking
Manage internal and client communications regarding TMF activities, escalations, and operational updates
Participate in client and ICON audits/inspections, ensuring TMF readiness and compliance
Drive process improvements and standardization initiatives to streamline TMF operations and enhance efficiency
Coordinate with cross-functional study teams to meet contractual obligations, quality targets, and timelines
Support department head in special projects, including new system implementation and workflow optimization
Travel up to 25% domestically or internationally, as required
Required Qualifications & Experience
Minimum 12+ years of experience in TMF operations and clinical study start-up processes
3+ years of people management experience overseeing teams of 20–30 members
Bachelor’s degree in Medicine, Life Sciences, or a related field (or equivalent experience)
Proven expertise in document management, regulatory compliance, and clinical operations
Strong organizational skills with the ability to manage multiple projects simultaneously
Excellent written and verbal communication skills in English
Customer-focused with critical thinking, problem-solving, and conflict management abilities
Competent with standard office and document management software
Preferred Attributes
Ability to develop and implement new processes and SOPs
Experience managing TMF operations across multiple clients and therapeutic areas
Strong analytical skills with attention to detail and quality
Demonstrated ability to foster team development, training, and mentorship
What ICON Offers
Competitive salary packages with annual performance bonuses
Comprehensive health insurance and retirement plans for employees and families
Flexible work arrangements and a culture that supports work-life balance
Life assurance, wellness programs, and country-specific benefits such as childcare support, gym discounts, and travel subsidies
Opportunity to work in a global, inclusive environment with career growth potential
ICON plc is an equal opportunity employer committed to diversity, inclusion, and accessibility. Reasonable accommodations are available for applicants with disabilities throughout the recruitment process.
Apply Now to join ICON as a Manager in TMF Operations and be part of a global team advancing clinical research and patient outcomes.
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