Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Centralized Study Analyst – Fortrea

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Job Listings

Pharma

Compensation & Advantages

Location

Bangalore, India

Job Type

Full-time (Hybrid)

Experience Required

3–5 years of experience in Clinical Research, Clinical Operations, Clinical Trial Management, or Study Coordination.
Prior experience working with clinical systems, eTMF, CTMS, EDC, and ICH-GCP guidelines is preferred.

Estimated Salary Package (Market Standard)

₹8 – ₹13 LPA (approx.), depending on experience, skills, and interview performance.

Job Overview

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Libraries

data

pharmaceutical industry

Pharmaceuticals & Biotech

The Centralized Study Analyst provides operational and administrative support for global clinical studies by managing study systems, documentation, data review, investigator payments, and study communications.



The role ensures regulatory compliance, supports study teams, and contributes to the smooth execution of clinical trials throughout the study lifecycle.

Key Responsibilities

Clinical Study Support

Manage clinical systems and user access.
Maintain study databases such as CTMS, IWRS, EDC, and related systems.
Support study teams with data review and operational activities.
Track and follow up with Clinical Research Associates (CRAs) on outstanding actions.
Generate study-specific reports and perform data analysis.
Manage internal and external study communications.
Monitor training compliance for study teams.
Support study start-up and close-out activities.

Document Review & eTMF Management

Review Investigator Packages for regulatory compliance.
Review amended Informed Consent Forms (ICFs) for compliance with sponsor and regulatory requirements.
File study documentation in TMF and eTMF systems.
Review Investigator Package P

📌 Centralized Study Analyst (Bengaluru)
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