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Manager – Tmf Operations

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ICON
6-10 years
Not Disclosed
Chennai, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Manager – TMF Operations

Location: Chennai, India
Work Mode: Office With Flex
Job Type: Full-Time
Experience Required: Minimum 6–10+ Years in TMF Management, Clinical Operations, or Clinical Research Documentation
Industry: Clinical Research / Pharmaceutical / CRO


Job Overview

We are seeking an experienced and detail-oriented Manager – TMF Operations to lead Trial Master File (TMF) operations and ensure regulatory-compliant clinical trial documentation management across global studies. The selected candidate will oversee TMF processes, audit readiness, documentation quality, and cross-functional collaboration while managing a high-performing TMF operations team.

This role is ideal for professionals with expertise in TMF management, clinical operations, regulatory compliance, electronic TMF systems, and clinical trial documentation within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

TMF Operations & Clinical Documentation Management

  • Lead and manage the TMF Operations team responsible for maintaining Trial Master Files (TMFs) across multiple clinical studies.
  • Ensure TMF documentation is:
    • Accurate
    • Complete
    • Inspection-ready
    • Regulatory compliant
  • Oversee collection, review, filing, and maintenance of essential clinical trial documents throughout the study lifecycle.

Regulatory Compliance & Audit Readiness

  • Ensure compliance with:
    • ICH-GCP guidelines
    • Global regulatory requirements
    • Clinical trial documentation standards
    • Sponsor SOPs
  • Maintain TMF readiness for:
    • Regulatory audits
    • Client inspections
    • Quality reviews
  • Identify documentation gaps and ensure timely corrective actions.

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Operations
    • Regulatory Affairs
    • Quality Assurance
    • Study Teams
    • External stakeholders
  • Support alignment of TMF activities with:
    • Clinical study timelines
    • Regulatory expectations
    • Operational goals
  • Facilitate effective communication across global project teams.

TMF Strategy & Process Improvement

  • Develop and implement:
    • TMF management strategies
    • Documentation procedures
    • Quality improvement initiatives
    • Operational best practices
  • Monitor TMF quality metrics and identify opportunities for:
    • Process optimization
    • Workflow enhancement
    • Compliance improvements
    • Efficiency gains.

Team Leadership & Staff Development

  • Lead, mentor, and train TMF staff within a regulated clinical research environment.
  • Foster a culture focused on:
    • Quality
    • Compliance
    • Accountability
    • Continuous improvement
  • Support employee development, performance management, and operational excellence initiatives.

Electronic TMF Systems & Technology Management

  • Manage and oversee:
    • Electronic TMF (eTMF) systems
    • Document management tools
    • Digital clinical documentation workflows
  • Ensure systems support:
    • Regulatory compliance
    • Data integrity
    • Inspection readiness
    • Efficient document tracking and management.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Life Sciences
    • Clinical Research
    • Pharmacy
    • Biotechnology
    • Healthcare
    • Or related scientific disciplines

Preferred Qualification

  • Advanced Degree or certifications in:
    • Clinical Operations
    • TMF Management
    • Clinical Research
    • Document Management
    • Regulatory Affairs