Position: Clinical Data Coordinator – I
📍 Location: Mumbai
🏢 Category: Clinical
🆔 Job ID: 254474
Job Overview
The Clinical Data Coordinator – I supports the Lead Data Manager (LDM) in reviewing, maintaining, and updating external vendor data received from central or local laboratories. The role ensures data integrity, consistency, and compliance with departmental SOPs, global standards, and regulatory guidelines.
Key Responsibilities
Data Management & Review
Ensure electronic vendor data contains all protocol-specified parameters, is correctly formatted, and accurately populates fields and patient records.
Support LDM in developing Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) for vendor data transfers.
Review data discrepancies identified by study-specific edit checks and manage subsequent queries.
Perform validation reviews on transmitted data for a sample of patients to ensure accuracy before database loading.
Assist in reviewing External Data edit checks, status reports, and listings.
Vendor & Clinical Coordination
Collaborate with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges.
Research and resolve discrepancies in laboratory ranges and maintain documentation.
Enter and perform QC of local laboratory normal ranges, ensuring proper linkage to patient results in the database.
Support LDM in communicating issues related to data transfers, validation, or data points to vendors and clients.
Compliance & Documentation
Adhere to ICH-GCP principles, company SOPs, and global standards.
Maintain confidentiality of data and sensitive information.
Other Duties
Perform additional tasks or project-related duties as assigned.
Qualifications
Education
University/College degree in Life Sciences, Health Sciences, Information Technology, or related field, or certification in allied health professions.
Relevant or equivalent experience may be considered in lieu of formal education.
Fluent in English (written and verbal).
Experience
Minimum 3 years of experience in pharmaceuticals, biotechnology, medical devices/diagnostics, or clinical trials.
Basic understanding of medical terminology is a plus.
Strong organizational, planning, and critical-thinking skills.
Excellent written and verbal communication skills for sponsor and internal interactions.
Ability to manage multiple tasks and priorities under tight deadlines.
Proficiency in Microsoft Office Suite and strong technical aptitude.
Work Environment & Physical Demands
General or remote office setting.
Prolonged periods of sitting and working at a computer.
Frequent interruptions and shifting priorities.
Must be flexible to work in shifts as per business requirements.
Equal Opportunity
Fortrea is an Equal Opportunity Employer. Learn more about EEO & Accommodations here.
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