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Clinical Nurse Reviewer I

Icon
ICON
2+ years
Not Disclosed
Chennai, India
1 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: 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

Clinical Nurse Reviewer I

Location: Chennai, India
Work Mode: Office With Flex
Job Type: Full-Time
Experience Required: Minimum 2+ Years in Clinical Research, Drug Development, or Healthcare Industry
Industry: Clinical Research / Healthcare / Pharmaceutical / CRO


Job Overview

We are seeking a detail-oriented and clinically experienced Clinical Nurse Reviewer I to support endpoint adjudication activities within global clinical trials. The selected candidate will work closely with project management and clinical operations teams to review clinical endpoint documentation, manage adjudication packages, and support physician adjudicators with accurate and medically complete clinical data.

This role is ideal for Registered Nurses (RN) with expertise in clinical research, clinical documentation review, endpoint adjudication, and healthcare data management within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Clinical Endpoint Documentation Review

  • Support the collection and review of:
    • Clinical endpoint documents
    • Source documentation
    • Adjudication dossiers
    • Clinical trial records
  • Ensure all adjudication packages are:
    • Accurate
    • Medically complete
    • Quality checked
    • Ready for physician review
  • Assist physician adjudicators by organizing complete and logical clinical case summaries.

Clinical Data & Case Management

  • Manage case-related information including:
    • Medical conditions
    • Laboratory results
    • Procedures
    • Adverse event data
  • Compile detailed narrative summaries for endpoint review activities.
  • Ensure proper coding using:
    • MedDRA
    • Clinical endpoint databases
  • Identify and address potential unblinding risks within clinical trial documentation.

Clinical Trial Coordination & Reporting

  • Collaborate with:
    • Project Management teams
    • Clinical Operations teams
    • Endpoint Committees
    • Clinical Sites
  • Generate:
    • Status reports
    • Progress tracking reports
    • Committee documentation
    • Quality performance reports
  • Respond to queries from:
    • Physician adjudicators
    • Clinical site personnel
    • Internal project stakeholders.

Regulatory Compliance & Quality Standards

  • Ensure compliance with:
    • Good Clinical Practice (GCP)
    • FDA regulations
    • International clinical standards
    • Company SOPs
  • Support quality control processes related to:
    • Clinical endpoint adjudication
    • Source documentation review
    • Data verification activities.

Required Qualifications

Educational Qualifications

Mandatory Qualification:

  • Registered Nurse (RN)

Preferred Qualifications

  • Bachelor’s Degree in:
    • Nursing
    • Life Sciences
    • Healthcare
    • Clinical Research
    • Or related healthcare disciplines

Experience Requirements

Required Experience

  • Minimum 2+ years of relevant experience in:
    • Clinical Research
    • Drug Development
    • Healthcare Industry
    • Clinical Data Review
    • Endpoint Adjudication
    • CRO or Pharmaceutical environments

Preferred Experience

  • Experience with:
    • FDA regulations
    • MedDRA coding
    • eCRFs
    • Clinical data management
    • Endpoint review processes

Freshers are not eligible for this role.