Senior CDC / CDC II – Clinical Data Coordinator
Company
ICON plc – A global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and treatments.
Job Details
Job Title: Senior CDC / CDC II
Job Requisition ID: JR140784
Employment Type: Full-time
Work Mode: Office Based / Office with Flex
Locations:
Chennai, India
Trivandrum, India
About the Role
ICON is looking for a Senior Clinical Data Coordinator (CDC/CDC II) to join its Clinical Data Management team. In this role, you will support the design, coordination, review, and quality management of clinical trial data while ensuring compliance with regulatory and industry standards.
You will work closely with cross-functional teams to maintain high-quality clinical data and contribute to the successful execution of clinical studies.
Key Responsibilities
1. Clinical Data Management
Create and maintain:
Data Management Plans (DMPs)
Study-related documentation
Ensure compliance with:
Industry standards
Regulatory requirements
Study protocols
2. Data Quality & Issue Resolution
Identify and resolve:
Data discrepancies
Data quality issues
Query management concerns
Improve data flow and study efficiency throughout the study lifecycle.
3. Cross-functional Collaboration
Work closely with:
Clinical Operations
Biostatistics teams
Other project stakeholders
Develop and implement study-specific data management strategies.
4. Study Coordination Activities
Support study timelines through activities such as:
Filing and archiving study documents
Dispatching queries to investigator sites
Tracking issue resolution
5. Mentorship & Team Support
Mentor and guide junior Data Coordinators.
Provide expertise in:
Data reconciliation
Medical coding
Data cleaning procedures
Required Qualifications
Education
Bachelor’s degree in:
Life Sciences
Healthcare
Or a related field
Experience
Proven experience in:
Clinical Data Management
Pharmaceutical or Biotechnology industry
Technical Skills
Familiarity with clinical data management systems such as:
Medidata
Oracle RDC
Similar EDC platforms
Core Skills
Strong attention to detail
Ability to work in a fast-paced environment
Excellent communication and teamwork skills
Strong organizational and problem-solving abilities
Preferred Knowledge
Understanding of:
ICH-GCP guidelines
Regulatory standards and compliance requirements
Employment Requirement
Employment with ICON is subject to having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON provides a comprehensive benefits package that may include:
Competitive salary and performance incentives
Medical, dental, and vision insurance
Retirement and pension plans
Life and disability insurance
Employee wellness and assistance programs
Structured learning and career development opportunities
Benefits may vary by role and location.
Inclusion & Accessibility
ICON is an equal opportunity employer committed to maintaining an inclusive and accessible workplace where all employees feel valued and supported.
Reasonable accommodations during the recruitment process are available upon request.
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Warsaw |