Senior eClinical Systems Analyst
On-site · Pune, Maharashtra, India
Job Summary
Senior eClinical Systems Analyst responsible for overseeing TMF quality reviews, regulatory document management for FDA submissions, and maintenance of eTMF/CTMS systems. Core duties include creating TMF quality plans, performing periodic quality reviews across active study sites, compiling regulatory documents (IRB renewals, protocol approvals, consent reviews, PI CVs, 1572 forms, CLS/CLIA-related documents, lab norms), ensuring metadata accuracy, supporting Study Start Up and close-out activities, providing metrics and KPI reporting, and mentoring eClinical Analysts. Requires robust knowledge of eClinical systems, TMF processes, ICH/GCP guidelines, and experience with document control and QA within clinical trials; proficient with MS Office and able to liaise with Study Owners, Project Managers, and clients for issue resolution and inspection readiness.
Required Qualifications
- 3 years+ of experience in Life Sciences (pharma/biotech/CRO)
- Strong experience with TMF documents including filing and QC
- Proven experience with electronic documentation and electronic TMF
- Strong knowledge of ICH/GCP Guidelines
- Knowledge of clinical development phases and processes
- Proficiency in Microsoft Office
- Ability to build relationships with clients and co-workers
- Excellent leadership skills
- Detail-orientated and well organized
- Critical thinker
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