Senior Clinical Data Coordinator (CDC / CDC II)
Locations: Chennai, India / Trivandrum, India
Job Type: Full-time
Work Model: Office with Flex
Organization: ICON plc
About the Organization
ICON plc is a global healthcare intelligence and clinical research organization focused on advancing clinical development through data-driven innovation. The organization emphasizes high-quality clinical trials, regulatory compliance, and patient-centered research.
Role Overview
The Senior Clinical Data Coordinator plays a key role in clinical trial data management, ensuring data quality, integrity, and compliance throughout the study lifecycle.
The role involves collaboration with cross-functional clinical teams and contributes to the successful execution of global clinical studies.
Key Responsibilities
1. Data Management & Quality Control
Develop and maintain detailed Data Management Plans (DMPs)
Ensure compliance with regulatory standards and industry guidelines
Identify and resolve data discrepancies across clinical studies
Maintain high-quality, accurate, and complete clinical trial data
2. Study Support & Execution
Support study-level data management activities across the trial lifecycle
Ensure timely completion of study deliverables and milestones
Manage query generation, distribution, and resolution with investigator sites
Support documentation filing, archiving, and study maintenance tasks
3. Cross-Functional Collaboration
Work closely with Clinical Operations, Biostatistics, and other study teams
Contribute to development of data management strategies for studies
Ensure alignment of data workflows with study protocols
4. Leadership & Mentorship
Mentor and guide junior clinical data coordinators
Support training on data cleaning, reconciliation, and coding processes
Promote best practices in clinical data management
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Healthcare, or related field
Experience
Prior experience in clinical data management in pharmaceutical, biotech, or CRO environments
Technical Skills
Experience with clinical data management systems such as:
Medidata Rave
Oracle RDC
Similar EDC platforms
Strong understanding of data cleaning, reconciliation, and coding processes
Knowledge Areas
Clinical trial processes and lifecycle
ICH-GCP guidelines and regulatory compliance (preferred)
Clinical data standards and quality requirements
Soft Skills
Strong attention to detail
Excellent communication and teamwork abilities
Ability to work in fast-paced, deadline-driven environments
Problem-solving and coordination skills
Core Competencies
Clinical data management
Quality assurance
Cross-functional collaboration
Process compliance
Mentorship and leadership support
Equal Opportunity Statement
ICON plc is committed to fostering an inclusive and diverse workplace. All qualified applicants are considered without discrimination based on race, gender, disability, religion, or other protected characteristics.
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