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 the Clinical Data Management (CDM) team by delivering high-quality data management solutions for clinical trials. The role involves coordinating clinical data activities, reviewing and validating study data, developing and testing clinical databases, resolving data queries, performing clinical coding, ensuring compliance with SOPs and regulatory standards, and collaborating with cross-functional teams to maintain data quality and integrity throughout the clinical trial lifecycle.
KEY RESPONSIBILITIES
Clinical Data Management
Coordinate clinical data management activities for assigned studies.
Serve as Data Operations Coordinator (DOC) for assigned clinical protocols or laboratory studies.
Support clinical trial data collection and management.
Maintain accurate clinical study documentation.
Ensure timely completion of assigned deliverables.
Clinical Database Development
Develop and test clinical study databases.
Create and validate edit specifications.
Support database configuration and maintenance.
Perform database testing activities.
Assist with database design under guidance.
Data Review & Query Management
Conduct clinical data review.
Identify and resolve data discrepancies.
Write and manage data clarification queries.
Monitor data quality throughout study execution.
Ensure completeness and consistency of clinical data.
Clinical Data Coding
Perform clinical data coding activities.
Apply medical terminology during coding processes.
Ensure coding accuracy and regulatory compliance.
Support standardized clinical data classification.
Maintain coding documentation.
Quality Assurance & Compliance
Follow company SOPs and working instructions.
Ensure compliance with GCP and clinical data management standards.
Participate in database audit activities.
Maintain audit-ready documentation.
Support continuous quality improvement initiatives.
Cross-Functional Collaboration
Work closely with Clinical Data Management teams.
Collaborate with Data Team Leads (DTLs) and Data Operations Coordinators (DOCs).
Maintain effective communication with project stakeholders.
Support cross-functional clinical trial activities.
Build productive working relationships with internal teams and clients.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Clinical Sciences
Life Sciences
Biological Sciences
Mathematics
Biotechnology
Pharmacy
Biomedical Sciences
Or a related scientific discipline
Equivalent education, training, and relevant experience may also be considered.
EXPERIENCE REQUIREMENTS
Required
Experience or knowledge in Clinical Data Management.
Exposure to clinical research or clinical trial data processes.
Understanding of medical terminology.
Experience with clinical database development, testing, or data review is advantageous.
Preferred
Experience as a Data Operations Coordinator (DOC) or similar role.
Experience with clinical coding and query management.
Knowledge of GCP and clinical data management standards.
Familiarity with EDC systems and clinical database platforms.
Uttar Pradesh :
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