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Centralized Study Analyst

Fortrea
0-5 years
Not Disclosed
Bangalore, India
10 May 28, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Centralized Study Analyst

Company

Fortrea – A global clinical research organization supporting the development of innovative therapies through clinical trial services and solutions.


Job Details

  • Job Title: Centralized Study Analyst

  • Job Requisition ID: 262483

  • Employment Type: Full-time

  • Work Mode: Hybrid

  • Location: Bangalore, India

  • Application Deadline: June 30, 2026


About the Role

The Centralized Study Analyst supports clinical trial operations with a focus on contract management, site agreement execution, and protocol amendment coordination.

This role ensures timely execution of clinical trial agreements and amendments while maintaining compliance with regulatory standards and internal SOPs.


Key Responsibilities

1. Clinical Trial Agreements (CTAs) & Contract Management

  • Draft, review, negotiate, and finalize:

    • Clinical Trial Agreements (CTAs)

    • Confidentiality agreements

    • Amendments and related documentation

  • Coordinate with:

    • Sponsors

    • Legal teams

    • Clinical operations teams

  • Ensure timely execution of contracts within study timelines.

2. Contract Tracking & Documentation

  • Maintain accurate contract status in systems such as:

    • SAMS

    • UCV

    • Other tracking tools

  • Track execution progress and ensure proper filing of documents.

  • Provide regular updates to stakeholders.

3. Risk & Issue Management

  • Identify delays, risks, and contracting issues.

  • Escalate issues to management when required.

  • Support resolution of contract-related challenges.

4. Protocol Amendments Management

  • Coordinate protocol amendment submissions and updates.

  • Communicate required changes to sites and internal teams.

  • Track amendment progress through approval and implementation stages.

  • Support contract and budget revisions related to protocol changes.

5. Cross-functional Collaboration

  • Work closely with:

    • Clinical Operations

    • Regulatory teams

    • Legal departments

    • Finance teams

  • Ensure smooth execution of amendments and study updates.

6. Compliance & Quality Assurance

  • Ensure adherence to:

    • SOPs

    • Sponsor requirements

    • ICH-GCP guidelines

  • Maintain audit-ready documentation.

7. Reporting & Process Improvement

  • Maintain trackers, metrics, and study reports.

  • Support process improvement initiatives.

  • Contribute to operational efficiency and quality improvements.


Required Qualifications

Education

  • University/College degree (Life Sciences preferred), or equivalent healthcare certification (e.g., nursing, lab technology).

Experience

  • 3–5 years of experience in clinical research.

  • Experience with:

    • Clinical trial contracting

    • Protocol amendments

    • ICH-GCP guidelines


Skills & Competencies

  • Strong understanding of clinical trial operations and contracting processes.

  • Excellent communication and negotiation skills.

  • Strong organizational and multitasking abilities.

  • High attention to detail.

  • Ability to manage multiple studies and deadlines.

  • Proficiency in contract tracking systems and MS Office tools.

  • Strong stakeholder management skills.


Additional Requirements

  • Ability to work in a general office environment.

  • Strong collaboration and teamwork skills.

  • Ability to consistently deliver high-quality work.


Employment Requirement

Employment is subject to having the legal right to work in the country where the role is based.


Inclusion & Accessibility

Fortrea is committed to equal opportunity employment and maintaining an inclusive workplace.

Reasonable accommodations are available during the recruitment process upon request.