eClinical Systems Analyst – (eTMF) Clinical Trial Documentation Job in Pune

Published on

October 20, 2025

eClinical Systems Analyst

Transperfect

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Pune

2–5 years

Verified Job

Online Application

Are you passionate about clinical research and digital trial management? A leading clinical services company in Pune is hiring an eClinical Systems Analyst to support Trial Master File (TMF), Clinical Trial Management System (CTMS), and Study Start-Up (SSU) operations.

This is a full-time, on-site position offering the chance to work closely with global clients, ensuring compliance with ICH-GCP standards and maintaining inspection-ready documentation for successful clinical trials.

Key Responsibilities

Collaborate with Study Owners on start-up, maintenance, and closeout of TMF activities.
Manage eTMF user access, placeholders, and event tracking.
Conduct TMF quality reviews to ensure accurate metadata and complete documentation.
Perform periodic quality checks on regulatory site documents (IRB, 1572, PI CVs, etc.).
Draft and review TMF Quality Plans and Reports.
Support FDA submission documentation under GCP and ICH guidelines.
Identify TMF issues, trends, and assist in resolution and reporting.
Prepare and analyze TMF KPIs – completeness, quality, and timeliness.
Maintain CTMS data entry and analysis for enterprise-level clients.
Support inspection readiness via storyboard documentation.
Participate in meetings, maintaining minutes and agendas.
Execute other relevant tasks assigned by supervisors.

Qualifications & Skills

Bachelor’s degree in Life Sciences, Pharmacy, or related field.
2–5 years of experience with eClinical systems (TMF, CTMS, SSU).
Strong understanding of clinical trial processes and GCP/ICH guidelines.
Proficiency in TMF quality review and document reconciliation.
Excellent attention to detail and communication skills.
Ability to manage multiple clinical projects simultaneously.