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Clinical Data Coordinator I / Clinical Data Coordinator Ii (Cdc I / Cdc Ii)

Icon Plc
ICON PLC
0-2 years
preferred by company
Bangalore, India
1 May 18, 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

Clinical Data Coordinator I / Clinical Data Coordinator II (CDC I / CDC II)

Location: Bangalore, India / Trivandrum, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office with Flex (Hybrid)
Industry: Clinical Research | Clinical Data Management | CRO | Pharmaceutical | Biotechnology
Department: Clinical Data Management
Job Reference ID: JR137696

Job Overview

ICON plc is hiring Clinical Data Coordinator I / Clinical Data Coordinator II (CDC I / CDC II) for its clinical data management team in Bangalore and Trivandrum, India. This hybrid opportunity is ideal for professionals with expertise or interest in clinical data management, eCRF development, query management, clinical data review, data validation, and clinical trial data quality management.

The selected candidate will support clinical trial data management activities, ensuring accurate, compliant, and high-quality clinical datasets for global research programs. This role involves collaboration with Data Management Study Leads, Clinical Data Scientists, investigational sites, and cross-functional teams.

This position is ideal for professionals seeking growth in clinical data management, CRO operations, pharmaceutical clinical research, and global trial data delivery.

Job Responsibilities

Clinical Data Management Support

  • Support day-to-day clinical data management activities across assigned clinical studies.
  • Ensure high-quality data review, issue resolution, and compliance with study timelines.
  • Contribute to accurate and audit-ready clinical trial datasets.

eCRF Development & Study Documentation

Assist the Data Management Study Lead with:

  • eCRF development
  • Data Validation Specifications (DVS)
  • Study Specific Procedures (SSPs)
  • Clinical data documentation
  • Study data workflow support

Ensure study deliverables align with protocol and data management requirements.

Clinical Data Review & Validation

  • Review:
    • Clinical trial data
    • Third-party vendor data
    • External datasets
    • Validation outputs

Perform review activities according to:

  • Edit specifications
  • Data review plans
  • Clinical data quality standards

Query Management

  • Generate clear, accurate, and concise queries for investigational sites.
  • Support timely query resolution.
  • Follow up with sites to ensure data discrepancies are addressed efficiently.

Stakeholder Communication

Collaborate effectively with:

  • Clinical Data Scientists
  • Data Management Study Leads
  • Functional management
  • Cross-functional project teams
  • Investigational sites

Maintain strong communication to support study timelines.

Study Operations Support

Provide support for operational study activities including:

  • Filing study documentation
  • Archiving study records
  • Query dispatch management
  • Administrative clinical data tasks
  • Timeline support activities

Ensure smooth clinical study execution.

Regulatory Compliance & Quality Oversight

Ensure compliance with:

  • ICH-GCP guidelines
  • Clinical data management standards
  • Internal SOPs
  • Sponsor/client quality expectations
  • Clinical trial documentation requirements

Maintain inspection-ready processes.

Educational Qualification

Candidates must have:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Healthcare
    • Biomedical Sciences
    • Clinical Research
    • Related relevant discipline

Experience Requirements

For CDC I

  • 0–2 years of relevant experience
  • Freshers with strong understanding of clinical research concepts may be considered