"eClinical Systems Analyst Jobs in Pune | Clinical Research & TMF/CTMS Careers 2025"
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| (eClinical Systems Analyst Jobs in 2025) |
You are passionate about clinical research and digital trial operations?
A leading global clinical services organization based in Pune, Maharashtra, is inviting applications for the position of eClinical Systems Analyst.
This full-time, on-site role offers an exciting opportunity to work on Trial Master File (TMF), Clinical Trial Management System (CTMS), and Study Start-Up (SSU) activities — ensuring compliance with ICH-GCP guidelines and supporting inspection-ready documentation for successful clinical trials.
Job Overview:-
Position: eClinical Systems Analyst
Industry: Clinical Research / Life Sciences
Location: Pune, Maharashtr
Job Type: Full-Time (On-site)
Experience Required: 2–5 Years
Salary Range: ₹6,00,000 – ₹10,00,000 per annum
Company Type: Global Clinical Services Provider
Key Responsibilities:-
As an eClinical Systems Analyst, you will play a vital role in supporting clinical trial operations and ensuring documentation excellence across TMF, CTMS, and SSU systems.
Your responsibilities include:
Coordinating with Study Owners for start-up, maintenance, and closeout of TMF activities.
Managing eTMF access controls, placeholders, and event tracking.
Conducting TMF quality checks and metadata reviews to ensure completeness and accuracy.
Performing regulatory document reviews — including IRB approvals, Form 1572, and PI credentials.
Creating and maintaining TMF Quality Plans and Reports.
Supporting FDA submission documentation aligned with GCP and ICH standards.
Tracking and resolving TMF issues and compliance trends.
Preparing TMF performance metrics (KPIs) for quality, completeness, and timeliness.
Managing and updating CTMS entries for project tracking and analytics.
Maintaining inspection readiness documentation and storyboards.
Supporting meetings through documentation, minutes, and progress summaries.
Required Qualifications & Skills:-
To be eligible for this role, candidates must have:
A Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline.
2–5 years of hands-on experience in eClinical systems (TMF, CTMS, or SSU).
Strong understanding of clinical research processes and ICH-GCP compliance.
Proven expertise in TMF document review, reconciliation, and audit preparation.
Excellent communication, organization, and attention-to-detail skills.
Ability to handle multiple global projects in a fast-paced environment.
Benefits:-
Working in this position offers excellent career growth in the global clinical research ecosystem.
Key benefits include:
Competitive annual package (₹6 – ₹10 LPA, based on experience).
Exposure to international clinical operations and eClinical platforms.
Hands-on experience with TMF and CTMS systems used by global CROs.
Collaborative team culture focused on quality and compliance.
Opportunities for career advancement and professional training.
How to Apply:-
Eligible candidates can apply directly through the official job portal using the link below:
👉 Apply Now – eClinical Systems Analyst at TransPerfect
Start your journey in digital clinical operations today and become part of a team that ensures clinical trial transparency, quality, and regulatory excellence worldwide.
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