Meta Title
TMF Specialist II Job Bangalore | Clinical Trial Documentation
Meta Description
Apply for TMF Specialist II role in Bangalore. Join ICON to manage TMF quality, audits, and clinical trial documentation with GCP and ICH compliance.
Meta Keywords
TMF specialist job Bangalore, clinical trial documentation India, TMF management role, clinical operations jobs India, GCP ICH guidelines TMF, pharmaceutical TMF specialist, eTMF system India
Job Summary
ICON plc, a global leader in clinical research and healthcare intelligence, is seeking a TMF Specialist II based in Bangalore, India. This role focuses on managing Trial Master File (TMF) documentation, quality checks, audit readiness, and supporting clinical trial compliance under GCP and ICH guidelines. The ideal candidate will have extensive TMF management experience in the pharmaceutical or CRO industry and strong knowledge of regulatory requirements. This is an excellent opportunity to advance your career in clinical operations with a reputable CRO offering competitive benefits.
Responsibilities
Perform quality checks and indexing of TMF documents for assigned in-house studies
Support compilation and maintenance of TMF Management Plans and TMF Index with TMF owners and CROs
Ensure timely flow and completeness of TMF documents; develop action plans for delays or issues
Prepare and assist in audits and inspections to maintain TMF inspection readiness
Provide regular TMF status reports and actionable metrics to project teams
Conduct re-training sessions for project teams as needed to ensure TMF compliance
Manage study setup and maintenance in the eTMF system and communicate updates to end users
Perform CRO TMF completeness reviews including metadata and missing item checks according to TMF Plans and Indices
Required Skills & Qualifications
Bachelor’s degree in life sciences, clinical research, or related field
Extensive experience in TMF management or clinical operations within pharmaceutical/CRO settings
Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements for TMF and clinical trial documentation
Experience working with eTMF systems and document management processes
Excellent organizational and communication skills with attention to detail
Perks & Benefits
Competitive salary (salary range not specified)
Various annual leave entitlements to promote work-life balance
Comprehensive health insurance plans for employees and their families
Competitive retirement savings plans to secure your financial future
Global Employee Assistance Programme (TELUS Health) providing 24/7 access to healthcare professionals
Life assurance and flexible country-specific benefits including childcare vouchers, gym discounts, travel subsidies, and health assessments
More details: https://careers.iconplc.com/benefits
Company Description
ICON plc is a world-renowned clinical research organization providing innovative healthcare intelligence and clinical trial management solutions. Dedicated to advancing drug development, ICON supports pharmaceutical and biotech companies globally in delivering new therapies.
Work Mode
On-site – Bangalore, India
Call to Action
Are you ready to take your career in clinical operations to the next level as a TMF Specialist II?
Apply today to join ICON’s dynamic team in Bangalore and play a vital role in clinical trial documentation and compliance!
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