Clinical Data Specialist
Company: IQVIA
Location: Kolkata, India
Department: Clinical Data Management (CDM)
Job Type: Full-Time
Work Mode: Hybrid
JOB OVERVIEW
The Clinical Data Specialist 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 data review, query management, database testing, clinical data coding, edit check development, and collaboration with cross-functional teams to ensure accurate, compliant, and timely delivery of clinical data throughout the clinical trial 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 completion of assigned deliverables.
Maintain high-quality clinical trial datasets.
Data Review & Validation
Review clinical trial data for completeness and accuracy.
Identify and resolve data discrepancies.
Write and manage data clarification queries.
Perform clinical data validation activities.
Ensure data quality throughout the study lifecycle.
Database Development & Testing
Assist in clinical database development.
Develop and test database edit checks.
Perform database validation and user acceptance testing.
Support programming and system testing activities.
Maintain database quality standards.
Clinical Data Coding
Perform medical and clinical data coding.
Apply standardized coding dictionaries.
Review coded clinical data for consistency.
Ensure coding accuracy and regulatory compliance.
Support data standardization activities.
Quality & Compliance
Follow Clinical Data Management SOPs and work instructions.
Ensure compliance with ICH-GCP and regulatory requirements.
Participate in database audit activities.
Maintain inspection-ready documentation.
Support continuous process improvements.
Collaboration & Communication
Collaborate with Data Team Leads (DTLs), Clinical Teams, and Project Managers.
Communicate study progress and data issues.
Maintain effective working relationships with cross-functional teams.
Support project objectives and study milestones.
Provide backup support for Data Operations Coordinators when required.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Clinical Sciences
Biological Sciences
Life Sciences
Mathematics
Statistics
Pharmacy
Biotechnology
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
Preferred
Experience with Clinical Data Management Systems (CDMS).
Knowledge of Electronic Data Capture (EDC) platforms.
Familiarity with MedDRA and WHO Drug coding.
Understanding of ICH-GCP guidelines.
Experience in clinical trial data review and query management.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
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Remote, India | Siliguri |Illinois :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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