CDC II
Company: ICON
Job Requisition ID: JR150695
Employment Type: Full-time
Work Mode: Office With Flex
Locations: Bangalore, Trivandrum, Chennai, India
Posted: 17 days ago
Role Overview
As a Clinical Data Coordinator II (CDC II) at ICON, you will be responsible for clinical data review and management activities across clinical trials. The role focuses on ensuring clinical data is complete, accurate, consistent, and inspection-ready while collaborating with Data Management teams and other trial stakeholders.
Key Responsibilities
Required Qualifications
Core Skills
Career Level / Role Fit
This is an intermediate-level clinical data management position. It would be particularly suitable for candidates with hands-on experience in clinical data review, query management, EDC systems, reconciliation, and pharmaceutical/biotechnology clinical trials.
Locations
Benefits
ICON may offer:
Employment with ICON is contingent upon having the legal right to work in the country where the position is based.
Equal Opportunity
ICON is committed to creating an inclusive and accessible workplace where qualified applicants are considered without discrimination. Reasonable accommodations are available during the recruitment process.
Review clinical data across databases, datasets, listings, reports, visualizations, and analytics for completeness, accuracy, and integrity.
Raise, review, and close data queries in EDC/CDMS systems, ensuring appropriate correction by qualified site personnel.
Work closely with Data Management trial partners and support additional Data Management activities.
Follow the Data Management Monitoring (DMM) process and Risk Assessment Categorisation Tool (RACT) for assigned trials.
Plan, coordinate, and assess risks associated with clinical data review using relevant tools and technologies.
Support the development and execution of data-review reports and data-review strategies.
Monitor data-review status and communicate updates to DM Trial Partners.
Collaborate with Trial Partners and other stakeholders to achieve data-review deliverables.
Potentially assume the Clinical Trial Data Manager (CTDM) role for assigned clinical trials.
Communicate data findings clearly, including through data visualizations.
Independently drive data-review activities under experienced Clinical Data Reviewer (CDR) oversight.
Take ownership and responsibility for assigned data-review activities.
Use data visualization techniques to identify trends and support operational decision-making.
Maintain relevant trial documentation and ensure ongoing archival.
Resolve or escalate issues identified during data review.
Prepare for and participate in audits and regulatory inspections.
Assist the Data Management Study Lead with maintenance of eCRFs, Data Validation Specifications, and Study-Specific Procedures.
Manage clinical and third-party data reconciliation based on edit specifications and data-review plans.
Track and communicate study and task metrics to clinical data scientists, project teams, and functional management.
Address data-related questions and recommend appropriate solutions.
Identify root causes of data issues and support systematic resolution.
Bachelor's degree in a relevant field such as Life Sciences or Healthcare.
Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry.
Familiarity with clinical data management systems such as:
Medidata
Oracle RDC
Similar EDC/CDMS platforms
Strong attention to detail.
Ability to work effectively in a fast-paced clinical research environment.
Excellent communication and collaboration skills.
Knowledge of regulatory guidelines and standards such as ICH-GCP is an advantage.
Clinical Data Management
Clinical Data Review
EDC/CDMS
Data Query Management
Data Reconciliation
Data Quality Review
Data Validation
Risk-Based Data Review
Data Visualization
Clinical Trial Documentation
Root-Cause Analysis
Audit and Inspection Readiness
ICH-GCP
Cross-functional Collaboration
Bangalore, India
Trivandrum, India
Chennai, India
Competitive base salary and performance-related incentives
Health and wellbeing programs
Medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance and wellbeing resources
Learning and development opportunities
Structured training and career development pathways
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