Manager, TMF Operations
Location: Bangalore, Karnataka, India
Work Model: Office with Flex
Employment Type: Full-Time
Industry: Clinical Research | CRO | Clinical Trial Operations
Company: ICON plc
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Manager, TMF Operations to lead and oversee Trial Master File (TMF) operations in Bangalore. This role is critical in ensuring regulatory compliance, inspection readiness, operational efficiency, and high-quality TMF delivery across multiple clinical studies and clients.
The position requires strong expertise in TMF operations, document management, people leadership, and process optimization, along with the ability to manage complex, multi-client environments in a global CRO setting.
Key Responsibilities
TMF & Document Management Leadership
Lead and manage end-to-end TMF and document management operations in alignment with ICON SOPs, work practices, client requirements, and global regulatory standards.
Oversee document lifecycle activities, including receipt, review, scanning, indexing, QC, filing, tracking, archiving, and retrieval.
Ensure TMF completeness, accuracy, and inspection readiness throughout the clinical trial lifecycle.
People Management & Capability Building
Manage, coach, and mentor large document management teams (20–30+ members) across multiple projects and clients.
Foster a culture of accountability, performance excellence, collaboration, and continuous improvement.
Partner with Corporate Training & Development to ensure staff training compliance and contribute to curriculum development when required.
Process Improvement & Operational Excellence
Evaluate existing TMF and document management processes for efficiency and effectiveness.
Design, implement, and optimize process improvements and new operational workflows to meet evolving business and client needs.
Develop study-specific TMF procedures and contribute to departmental initiatives and special projects.
Cross-Functional & Client Collaboration
Liaise with study teams, clinical operations, and global document management stakeholders to ensure contractual deliverables and quality targets are met.
Manage client communications, status reporting, and service-level commitments.
Support and participate in internal, client, and regulatory audits and inspections as required.
Compliance, Quality & Reporting
Ensure all TMF activities comply with ICH-GCP, regulatory requirements, and ICON quality standards.
Manage departmental quality control activities and escalate quality, training, or timeline risks to senior leadership.
Oversee activity tracking, metrics, and preparation of TMF status reports for internal and external stakeholders.
Additional Responsibilities
Coordinate TMF archiving activities and ensure proper maintenance of document storage areas and supplies.
Support domestic and international travel requirements (up to approximately 25%) as needed.
Handle special assignments and departmental initiatives as directed by leadership.
Required Qualifications & Experience
Education:
Bachelor’s degree (or local equivalent) in Life Sciences, Medicine, Pharmacy, or a related scientific discipline.
Experience:
12+ years of experience in TMF Operations / Document Management within a CRO, pharmaceutical company, or clinical research environment.
Strong understanding of clinical study start-up, trial conduct, and TMF regulatory requirements.
Minimum 3+ years of people management experience, managing large teams of 20–30 or more professionals.
Key Skills & Competencies:
Deep expertise in TMF processes, inspection readiness, and clinical document management systems.
Excellent organizational skills with the ability to manage multiple projects and competing priorities.
Strong written and verbal communication skills with fluency in English.
Proven ability in critical thinking, problem-solving, conflict resolution, and stakeholder management.
Customer-focused mindset with a strong commitment to quality and delivery excellence.
Proficiency in clinical systems and standard office software.
Why Join ICON
ICON is committed to building a high-performance, inclusive, and people-centric culture. Employees benefit from competitive compensation, comprehensive health and wellness programs, global career development opportunities, and flexible work arrangements designed to support work-life balance.
ICON values diversity, inclusion, and belonging, and provides equal employment opportunities to all qualified applicants regardless of background.
Equal Opportunity Statement
ICON is an equal opportunity employer and is committed to providing a workplace free from discrimination and harassment. Reasonable accommodations are available throughout the recruitment process and during employment for individuals with disabilities or medical conditions.
Apply Now
If you are a seasoned TMF Operations leader looking to advance your career in a global CRO environment, apply now to join ICON and contribute to advancing clinical research worldwide.
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