Clinical Data Specialist (CDS) / Senior Clinical Data Coordinator (Sr. CDC)
Company: IQVIA
Location: Bengaluru, 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) supports the Clinical Data Management (CDM) team by managing clinical trial data, ensuring data quality, developing and testing clinical databases, resolving data queries, performing clinical coding, and coordinating data management activities. The role also provides leadership support for assigned studies, contributes to database design and testing, and ensures clinical trial data meets regulatory and customer quality requirements.
KEY RESPONSIBILITIES
Clinical Data Management
Coordinate clinical data management activities for assigned studies.
Serve as Data Operations Coordinator (DOC) for assigned protocols.
Support multiple central laboratory studies.
Ensure timely and high-quality clinical data delivery.
Maintain data integrity throughout the study lifecycle.
Clinical Database Management
Develop and maintain clinical databases.
Create and test database structures.
Develop edit specifications for clinical studies.
Perform database validation and testing.
Support database design activities.
Data Cleaning & Query Management
Review clinical trial data for quality and consistency.
Generate and resolve data clarification forms (DCFs).
Perform data review and discrepancy management.
Ensure accurate and complete clinical datasets.
Support database lock activities.
Clinical Data Coding
Perform medical coding of clinical data.
Apply medical terminology accurately.
Ensure coding consistency and quality.
Support coding review activities.
Maintain coding standards.
Testing & Validation
Test clinical databases and programming outputs.
Validate edit checks and database functionality.
Perform user acceptance testing (UAT).
Support system validation activities.
Identify and resolve testing issues.
Leadership & Coordination
Serve as backup to Data Operations Coordinator (DOC).
Support Data Team Lead (DTL) activities.
Lead database audit teams when assigned.
Coordinate with cross-functional study teams.
Maintain effective communication with clients and internal stakeholders.
Regulatory & Quality Compliance
Follow Clinical Data Management SOPs.
Ensure compliance with regulatory requirements.
Maintain study documentation.
Support audit readiness.
Deliver high-quality clinical data products.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Clinical Sciences
Biological Sciences
Mathematical Sciences
Life Sciences
Pharmacy
Biotechnology
Or related discipline
Equivalent
Equivalent combination of education, training, and experience.
EXPERIENCE REQUIREMENTS
Required
Experience in Clinical Data Management or Clinical Research is preferred.
Preferred
Clinical Data Management (CDM)
Clinical Trials
Central Laboratory Studies
Clinical Database Management
Medical Coding
Clinical Data Review
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