Senior/ Lead eTMF coordinator/Clinical Research

Role & Responsibilities
• Manage end-to-end eTMF/TMF activities to support clinical trial operations and ensure inspection readiness
• Oversee collection, review, indexing, filing, and quality control of clinical trial documents within the eTMF system
• Ensure TMF completeness, accuracy, and timeliness in line with ICH-GCP and applicable regulatory guidance
• Perform periodic TMF quality checks, reconcile missing/expired documents, and drive follow-ups with stakeholders/vendors
• Coordinate with Clinical Operations, CROs, sites, and functional teams to ensure correct document workflows and version control
• Prepare TMF status/metrics reports and support audits/inspections by providing requested documentation and evidence
• Support process improvements, SOP adherence, and training/guidance to team members on TMF practices

Qualification
• Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, or related field

Experience
• 7 years of relevant experience in Clinical Operations and/or Clinical Document Management (eTMF preferred)

Skills
• Strong working knowledge of clinical research documents and TMF lifecycle management
• Knowledge of ICH-GCP and regulatory guidance for trial documentation
• Excellent verbal and written communication skills
• eTMF operations, document QC, reconciliation, and inspection readiness mindset
• Proficiency in Microsoft Office (Word, Excel, etc)

About The Company
VARITE INC is a staffing and talent solutions organization supporting clients with contract and full-time hiring across multiple domains. This role is a full-time on-site opportunity in Bengaluru (Manyata Tech Park) with compensation up to 15 LPA and a face-to-face interview process scheduled for the last week of February.