Clinical Data Coordinator II (CDC II) – ICON
Location
Trivandrum, India
Bangalore, India
Chennai, India
Work Mode
Office or Home (Hybrid/Flexible)
Job Type
Full-time
Department
Clinical Data Management / Clinical Research
Experience Required
Relevant experience in Clinical Data Management (CDM) within:
Pharmaceutical industry
Biotechnology industry
Clinical Research Organization (CRO) environment
Hands-on understanding of clinical trial data review, reconciliation, and data management processes preferred.
Estimated Salary Package (Market Standard)
₹8 – ₹15 LPA (approx.), depending on clinical data management experience, EDC system knowledge, and overall technical expertise.
Job Overview
The Clinical Data Coordinator II (CDC II) at ICON is responsible for supporting clinical data management activities for global clinical trials. The role involves maintaining clinical trial databases, managing data reconciliation activities, tracking study metrics, resolving data-related issues, and ensuring accurate and high-quality clinical data delivery.
The position requires collaboration with Data Management Leads, Clinical Data Scientists, project teams, and other stakeholders to support successful execution of clinical studies.
Key Responsibilities
Clinical Data Management Support
Assist Data Management Study Leads in maintaining:
Electronic Case Report Forms (eCRFs)
Data Validation Specifications (DVS)
Study-specific procedures
Support clinical data management activities according to study requirements and timelines.
Ensure clinical trial data quality, consistency, and completeness.
Data Review & Reconciliation
Manage reconciliation activities for:
Clinical data
Third-party data sources
Perform data review activities based on:
Edit specifications
Data review plans
Identify discrepancies and support timely resolution.
Data Issue Resolution
Address clinical data-related questions and provide appropriate solutions.
Perform root cause analysis for data issues.
Support corrective actions to improve data quality.
Escalate complex issues to relevant stakeholders.
Study Metrics Management
Track study and task-related performance metrics.
Communicate project status updates to:
Clinical Data Scientists
Project Teams
Functional Management
Support monitoring of study progress and deliverables.
Cross-Functional Collaboration
Work closely with:
Clinical Data Managers
Clinical Scientists
Project Managers
Functional teams
Participate in discussions related to clinical data review and study execution.
Support delivery of clinical trials within timelines and quality standards.
Educational Qualification
Required:
Bachelor’s degree in relevant fields such as:
Life Sciences
Healthcare Sciences
Pharmacy
Biotechnology
Related disciplines
Required Skills
Intermediate knowledge of Clinical Data Management processes.
Understanding of pharmaceutical or biotechnology clinical trials.
Familiarity with clinical data management platforms:
Medidata
Oracle RDC
Similar EDC systems
Strong attention to detail and analytical ability.
Good problem-solving skills.
Ability to manage multiple priorities in a fast-paced environment.
Excellent written and verbal communication skills.
Ability to collaborate with global teams.
Preferred Skills
Knowledge of regulatory standards:
ICH-GCP guidelines
Clinical trial documentation requirements
Data quality standards
Experience with:
eCRF management
Query management
Data validation
External data reconciliation
Exposure to global clinical research studies.
Work Environment
Flexible office/home-based work setup.
Collaboration with international clinical research teams.
Opportunity to work on global drug development programs.
Who Should Apply
Clinical Data Coordinators
Clinical Data Associates
Data Management Associates
Junior Clinical Data Managers
Professionals with experience in clinical trial data management, EDC systems, data review, reconciliation, and ICH-GCP-compliant processes looking to build a career in global clinical research.
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