Manager – TMF Operations
Location: Bangalore, Karnataka, India
Work Model: Office-Based (Flexible)
Employment Type: Full-Time
Experience Required: 12+ Years in TMF Operations
People Management Experience: Minimum 3+ Years (Managing 20–30 Team Members)
Travel Requirement: Up to 25% (Domestic and/or International)
About the Company
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in advancing clinical development programs worldwide. ICON partners with sponsors to deliver high-quality clinical trial services across all phases of drug development.
With a strong focus on accountability, collaboration, partnership, and integrity, ICON continues to shape the future of clinical research and regulatory compliance through operational excellence and innovation.
Role Overview
The Manager – TMF Operations will lead and oversee Trial Master File (TMF) document management activities for internal and client-sponsored clinical studies. This leadership role ensures regulatory compliance, operational efficiency, and high-quality TMF oversight aligned with global clinical trial standards and Good Clinical Practice (GCP).
The position requires deep expertise in TMF operations, study start-up processes, inspection readiness, and people leadership within a clinical research organization (CRO) environment.
Key Responsibilities
TMF & Document Management Leadership
Manage document management activities in accordance with client requirements, ICON SOPs/WPs, and global regulatory standards
Oversee document receipt, review, scanning, indexing, quality control, filing, forwarding, and archiving processes
Coordinate TMF archiving and ensure inspection readiness
Develop study-specific procedures and ensure proper maintenance of document storage areas
Ensure adequate document management supplies and infrastructure
Operational Excellence & Process Improvement
Drive continuous process improvement initiatives to enhance efficiency and value delivery
Evaluate existing TMF processes and recommend improvements to department leadership
Implement new business processes aligned with regulatory and client requirements
Manage departmental quality control activities and ensure adherence to compliance standards
Project & Client Management
Coordinate document management staff activities across multiple client projects
Generate and manage status reports for internal teams and sponsors
Liaise with study teams to ensure service-level and contractual commitments are met
Manage internal and external client requests and support audits (client and regulatory)
Provide guidance on study file archiving and regulatory documentation
People Leadership & Talent Development
Lead, mentor, and manage a team of 20–30 TMF professionals
Ensure timely completion of required training in collaboration with Corporate Training & Development
Identify training gaps and support curriculum development initiatives
Promote a culture of accountability, performance excellence, and compliance
Compliance & Regulatory Oversight
Ensure TMF operations align with global regulatory frameworks, ICH-GCP guidelines, and sponsor-specific requirements
Participate in audits and inspections as required
Inform leadership of quality issues, project risks, and operational timelines
Education & Qualifications
Bachelor’s Degree or equivalent qualification in Life Sciences, Medicine, Pharmacy, or related discipline (Required)
Advanced degree preferred
Experience Required
Minimum 12+ years of experience in TMF Operations within a CRO, pharmaceutical, or clinical research environment
Strong understanding of clinical trial start-up processes and regulatory documentation requirements
Minimum 3+ years of people management experience leading teams of 20–30 members
Proven experience managing multiple global clinical projects simultaneously
Experience supporting regulatory inspections and client audits
Core Competencies
Advanced knowledge of Trial Master File (TMF) management systems and GCP compliance
Strong organizational and multi-project management skills
Excellent written and verbal communication skills in English
High attention to detail and documentation accuracy
Critical thinking, problem-solving, and conflict resolution capability
Strong client-focused approach with stakeholder management expertise
Proficiency in clinical document management systems and enterprise platforms
Why Consider This Opportunity
This role offers senior-level leadership in clinical document management within a globally recognized CRO. It provides the opportunity to lead large TMF teams, drive regulatory compliance excellence, and contribute to global clinical development programs across therapeutic areas.
Professionals seeking growth in TMF leadership, clinical operations management, regulatory documentation oversight, and CRO leadership will find strong career progression opportunities in this role.
Equal Opportunity Statement
ICON plc is an equal opportunity employer committed to fostering an inclusive workplace free from discrimination and harassment. All qualified applicants will receive consideration without regard to protected characteristics under applicable laws.
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