Manager, TMF Operations
Job Details
Company: ICON
Job Requisition ID: JR151258
Department: TMF Operations
Locations: Chennai / Bangalore, India
Work Model: Office With Flex
Employment Type: Full-time
Travel Requirement: Approximately 25%
Industry: Clinical Research / Healthcare
Company Overview
ICON is a global healthcare intelligence and clinical research organization focused on accelerating the development of new medicines and treatments.
The organization operates with a strong emphasis on:
Integrity
Collaboration
Agility
Inclusion
Patient-focused clinical research
Role Overview
The Manager, Trial Master File (TMF) Operations will be responsible for overseeing the management, maintenance, quality, and compliance of Trial Master Files across multiple clinical studies.
The role combines TMF operations, team leadership, quality management, regulatory compliance, process improvement, and cross-functional collaboration.
The successful candidate will ensure that essential clinical trial documentation is complete, accurate, appropriately filed, inspection-ready, and maintained throughout the clinical trial lifecycle.
Key Responsibilities
TMF Operations Management
Manage the TMF Operations team responsible for maintaining Trial Master Files across multiple clinical studies.
Ensure TMF activities comply with:
Good Clinical Practice (GCP)
ICH guidelines
Global regulatory requirements
Client requirements
Internal procedures
Oversee TMF workstreams and ensure deliverables are completed within agreed timelines.
Manage competing priorities across multiple studies and projects.
Essential Document Management
Oversee the collection of essential clinical trial documents.
Review documents for completeness, accuracy, and compliance.
Ensure documents are appropriately filed in the TMF.
Monitor timely updates throughout the clinical trial lifecycle.
Identify missing, outdated, or incorrectly filed documentation.
Ensure appropriate documentation is available for inspection and audit purposes.
TMF Quality and Compliance
Ensure TMF completeness and quality across assigned clinical studies.
Monitor TMF quality metrics and performance indicators.
Identify documentation gaps and compliance risks.
Implement corrective actions where required.
Maintain a high level of TMF inspection readiness.
Ensure TMF activities remain aligned with regulatory and industry standards.
Audit and Inspection Readiness
Ensure TMFs are continuously prepared for:
Regulatory audits
Client inspections
Quality audits
Regulatory inspections
Identify and resolve documentation gaps before inspections.
Support responses to audit and inspection findings.
Coordinate remediation activities where deficiencies are identified.
Maintain appropriate evidence of corrective and preventive actions.
Cross-Functional Collaboration
Work closely with multiple internal and external stakeholders, including:
Clinical Operations
Regulatory Affairs
Quality Assurance
Clinical Study Teams
Project Teams
External stakeholders
Clients
Collaborate with these teams to ensure:
TMF completeness
Timely document submission
Appropriate document filing
Regulatory compliance
Audit readiness
Resolution of documentation issues
TMF Strategy and Process Improvement
Develop and implement TMF management strategies.
Establish and maintain TMF policies and procedures.
Improve TMF operational efficiency.
Identify opportunities for process optimization.
Monitor trends and recurring documentation issues.
Drive continuous improvement initiatives.
Implement industry best practices related to TMF management.
Quality Metrics and Performance Monitoring
Monitor TMF quality metrics.
Track document completeness and filing performance.
Analyze quality and operational trends.
Identify process gaps and improvement opportunities.
Develop and implement actions to improve TMF performance.
Report relevant performance indicators to leadership and stakeholders.
Team Leadership and People Management
Lead and manage the TMF Operations team.
Allocate work and manage team priorities.
Monitor team performance and deliverables.
Develop and mentor TMF staff.
Provide training on TMF processes, quality requirements, and regulatory expectations.
Foster a culture of quality, accountability, compliance, and continuous improvement.
Support employee development and capability building.
Training
Develop and deliver TMF-related training.
Ensure team members understand applicable:
TMF procedures
GCP requirements
ICH guidelines
Regulatory expectations
Document management requirements
Identify training needs and implement appropriate development plans.
Electronic TMF Systems
Work with electronic Trial Master File (eTMF) systems.
Ensure appropriate document management and filing practices.
Maintain regulatory compliance within electronic systems.
Monitor document quality and completeness within the eTMF.
Ensure electronic documentation remains inspection-ready.
Qualifications
Bachelor's degree in:
Life Sciences
Documentation Management
Clinical Research
Or a related discipline
Required Experience
Extensive experience in TMF management or clinical operations within:
Pharmaceutical companies
Contract Research Organizations (CROs)
Clinical research organizations
Healthcare research environments
Strong experience managing TMF activities across clinical studies.
Experience working in a regulated clinical research environment.
Proven experience managing and developing teams.
Regulatory Knowledge
Strong understanding of:
Good Clinical Practice (GCP)
ICH guidelines
Global regulatory requirements
Clinical trial documentation requirements
TMF management principles
Audit and inspection requirements
Document quality and compliance
Leadership Competencies
The ideal candidate should demonstrate:
Strong people-management skills.
Ability to develop and mentor team members.
Effective delegation and workload management.
Ability to manage competing priorities.
Strong decision-making skills.
Ability to drive team performance.
Ability to operate effectively in a fast-paced and regulated environment.
Project Management Skills
Strong organizational skills.
Strong project management capabilities.
Ability to oversee multiple clinical studies simultaneously.
Ability to manage timelines and competing priorities.
Strong attention to documentation quality.
Ability to identify and resolve operational issues.
Communication and Stakeholder Management
Excellent written and verbal communication skills.
Strong interpersonal skills.
Ability to collaborate across functional teams.
Experience working with internal and external stakeholders.
Ability to communicate risks, issues, and recommendations effectively.
Strong client-facing and stakeholder-management capabilities.
Technical Skills
Proficiency with electronic TMF systems.
Experience with document management systems.
Understanding of electronic document workflows.
Ability to monitor TMF quality and compliance through electronic systems.
General proficiency with relevant business and documentation tools.
Key Functional Areas
Trial Master File (TMF) Management
Electronic TMF (eTMF)
Clinical Operations
Clinical Trial Documentation
GCP Compliance
ICH Guidelines
Regulatory Compliance
Audit Readiness
Inspection Readiness
Document Quality Management
TMF Quality Metrics
Process Improvement
Team Management
Training and Development
Project Management
Stakeholder Management
Ideal Candidate Profile
The ideal candidate is an experienced TMF Operations professional with strong clinical research or pharmaceutical industry experience and proven people-management capabilities.
The candidate should have extensive knowledge of TMF management, essential document management, eTMF systems, GCP, ICH guidelines, regulatory compliance, audit readiness, and clinical trial documentation.
A strong candidate should also be capable of managing multiple studies, leading a TMF team, monitoring quality metrics, driving process improvements, and collaborating effectively with Clinical Operations, Regulatory Affairs, Quality Assurance, clients, and other stakeholders.
Travel
Approximately 25% travel may be required.
Key Success Factors
Success in this position will depend on the ability to:
Maintain complete and inspection-ready TMFs.
Lead and develop a high-performing TMF Operations team.
Ensure timely and accurate document filing.
Maintain GCP and regulatory compliance.
Identify and resolve documentation gaps.
Manage multiple clinical studies and competing priorities.
Drive TMF quality and process improvements.
Build strong relationships with cross-functional stakeholders.
Ensure readiness for audits and regulatory inspections.
Maintain consistently high documentation standards.
Employment Requirement
Employment with ICON is contingent upon the candidate having the legal right to work in the country where the position is based.
Benefits
ICON may provide a comprehensive rewards package that can include:
Competitive base salary
Performance-related incentives
Health and wellbeing programs
Medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programs
Wellbeing resources
Learning and development opportunities
Structured training and career development pathways
Benefits may vary depending on role and location.
Inclusion and Accessibility
ICON is committed to providing an inclusive and accessible workplace. The organization provides reasonable accommodations during the recruitment process for candidates who require them.
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