Clinical Data Coordinator I
Company
Fortrea – A global clinical research organization specializing in clinical trial operations, data management, and regulatory support services to ensure high-quality and compliant clinical research.
Job Details
Job Title: Clinical Data Coordinator I
Job Requisition ID: 26721
Employment Type: Full-time
Location: Bangalore, India
Application Deadline: June 30, 2026
About the Role
The Clinical Data Coordinator I supports clinical data management activities, focusing on external vendor data review, data validation, and ensuring compliance with study protocols and regulatory standards.
This role ensures accurate and consistent clinical trial data by maintaining data integrity across systems and coordinating with internal teams and external vendors.
Key Responsibilities
1. External Vendor Data Management
Review and maintain external vendor data from:
Central laboratories
Local laboratories
Ensure data aligns with:
Protocol specifications
Standard formats
System requirements
2. Data Quality & Validation
Review study-specific data edit checks.
Identify and resolve data discrepancies through query management.
Perform validation checks on electronically transferred data.
3. Data Transfer Support
Support development of:
Data Transfer Agreements (DTA)
Data Transfer Specifications (DTS)
Assist in ensuring correct and complete data transfers from vendors.
4. Laboratory Data Management
Collect and manage local laboratory normal ranges from clinical teams (CTM/CRA).
Validate and resolve discrepancies in lab reference ranges.
Ensure correct linkage of lab data to patient records.
5. System Review & Reporting
Review:
External data listings
Edit check outputs
Status reports
Ensure proper documentation and data accuracy.
6. Vendor & Stakeholder Communication
Communicate with vendors regarding:
Data transfer issues
Data validation problems
Data discrepancies
Support issue resolution under supervision.
7. Compliance & Quality Assurance
Ensure adherence to:
SOPs
Global clinical data standards
ICH-GCP guidelines
Maintain confidentiality of all clinical data.
Required Qualifications
Education
University/college degree in:
Life Sciences
Health Sciences
Information Technology
Or related field
Allied health certifications may also be considered
Experience
Minimum 3 years of experience in:
Pharmaceutical
Biotechnology
Medical device
Clinical research industries
Equivalent education + experience combinations may be considered
Skills & Knowledge
Strong understanding of:
Clinical trial data processes
Medical terminology (preferred)
ICH-GCP guidelines
Strong analytical and problem-solving abilities.
Excellent organizational and multitasking skills.
Ability to handle multiple priorities under pressure.
Strong communication skills (written and verbal).
Proficiency in Microsoft Office tools.
Strong technical aptitude.
Work Environment
Office or remote-based work setting.
Requires prolonged computer use.
May involve frequent interruptions and shifting priorities.
Flexible shift work may be required.
Inclusion & Accessibility
Fortrea is committed to equal opportunity employment and fostering an inclusive workplace.
Reasonable accommodations are available during the recruitment process upon request.
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