Clinical Data Coordinator I
Company: Fortrea
Job Title: Clinical Data Coordinator I
Job ID: 26721
Location: Bengaluru, Karnataka
Job Category: Clinical Data Management / Clinical Operations
Employment Type: Full-time
Work Mode: Office / Remote (Flexible)
Shift Requirement: Flexible shifts as per business needs
Job Summary
Fortrea is hiring a Clinical Data Coordinator I to support clinical data management activities related to external vendor data, laboratory data review, data integrity checks, discrepancy management, and coordination with clinical teams. The role focuses on maintaining accurate clinical trial data while ensuring compliance with SOPs, ICH-GCP standards, and global data management practices.
Key Responsibilities
Review and maintain external vendor clinical data received from laboratories or central vendors.
Ensure electronic vendor data:
Contains all protocol-required parameters
Is in the correct format
Maps accurately to patients and database fields
Support development of:
Data Transfer Agreements (DTA)
Data Transfer Specifications
Review study-specific edit checks and resolve external data discrepancies.
Perform query management for data issue resolution.
Support validation review of electronically transmitted data.
Review:
External Data edit checks
External Data status reports
External Data listings
Coordinate with Clinical Trial Managers (CTM) / Clinical Research Associates (CRA) to obtain laboratory normal ranges.
Research and resolve discrepancies in laboratory reference ranges.
Enter and perform QC for laboratory normal range data.
Ensure proper linking of lab normal ranges with patient results.
Support communication with vendors and clients regarding:
Data transfer issues
Validation concerns
Data discrepancies
Ensure compliance with:
SOPs
Global standards
ICH-GCP principles
Required Qualifications
University / College Degree in:
Life Sciences
Health Sciences
Information Technology
Related fields
OR
Certification in allied health professions
Equivalent relevant experience may also be considered.
Required Experience
Minimum 3 years of experience in:
Pharmaceutical industry
Biotechnology
Medical devices / diagnostics
Clinical trials industry
Preferred knowledge:
Basic medical terminology
Clinical trial data workflows
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