Clinical Data Specialist (CDS) / Senior Clinical Data Coordinator (Sr. CDC)
Company: IQVIA
Location: Kochi, India
Department: Clinical Data Management (CDM)
Job Type: Full-Time
Work Mode: Hybrid
JOB OVERVIEW
The Clinical Data Specialist (CDS) / Senior Clinical Data Coordinator (Sr. CDC) is responsible for supporting Clinical Data Management (CDM) activities by ensuring the collection, validation, review, coding, and maintenance of high-quality clinical trial data. The role involves clinical database management, data review, query management, database testing, clinical data coding, edit check development, and coordination with cross-functional teams to ensure timely, accurate, and regulatory-compliant clinical data throughout the study lifecycle.
KEY RESPONSIBILITIES
Clinical Data Management
Support Clinical Data Management activities for assigned clinical studies.
Serve as a Data Operations Coordinator (DOC) for assigned protocols or central laboratory studies.
Coordinate clinical data management tasks across study teams.
Ensure timely delivery of study milestones and deliverables.
Maintain high-quality clinical trial datasets.
Data Review & Query Management
Review clinical trial data for accuracy, completeness, and consistency.
Identify and resolve data discrepancies.
Create, manage, and resolve data clarification queries.
Perform ongoing data review activities.
Ensure timely query resolution with study teams.
Database Development & Testing
Assist in clinical database development and setup.
Develop and review edit check specifications.
Perform database validation and testing.
Support programming validation activities.
Ensure database quality and functionality.
Clinical Data Coding
Perform medical and clinical data coding.
Apply standardized medical coding dictionaries.
Review coded data for consistency and accuracy.
Support data standardization activities.
Ensure coding compliance with study requirements.
Quality & Compliance
Follow Clinical Data Management SOPs and work instructions.
Ensure compliance with ICH-GCP and regulatory guidelines.
Participate in database audit activities.
Maintain inspection-ready documentation.
Support continuous quality improvement initiatives.
Collaboration & Communication
Collaborate with Data Team Leads (DTLs), Clinical Operations, Biostatistics, and Project Teams.
Communicate study progress and data management updates.
Build effective working relationships with internal stakeholders.
Support project objectives and timelines.
Provide backup support to Data Operations Coordinators when required.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Clinical Sciences
Biological Sciences
Life Sciences
Pharmacy
Biotechnology
Mathematics
Statistics
Or a related discipline
Equivalent education and relevant experience may also be considered.
EXPERIENCE REQUIREMENTS
Required
Experience in one or more of the following:
Clinical Data Management
Clinical Data Review
Clinical Database Testing
Clinical Data Coding
Clinical Research
Database Validation
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Remote, India | Siliguri |Illinois :
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