Job Title: Clinical Data Coordinator - I
📍 Location: Mumbai
🏢 Category: Clinical
🆔 Job ID: 254474
Job Overview
The Clinical Data Coordinator-I supports the Local Data Manager (LDM) in reviewing, maintaining, and updating external vendor data from central vendors or local laboratories. The role ensures departmental SOPs, guidelines, and global standards are followed to maintain data integrity and consistency across projects.
Key Responsibilities
📊 Data Management
Ensure electronic vendor data contains all protocol-specified parameters, correct formatting, and accurate patient mapping.
Support LDM in developing Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) for vendor data.
Review data discrepancies generated by study-specific edit checks for external data and manage query resolution.
Perform validation reviews of electronically transmitted data for sample patient sets for loading purposes.
Review external data edit checks, status reports, and data listings.
🧪 Collaboration & QC
Interact with clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites.
Research and resolve discrepant information regarding normal ranges and maintain documentation.
Enter and perform QC for local laboratory normal ranges, ensuring proper attachment to patient results in the database.
Support communication to vendors and clients regarding data transfer, data point, and validation issues under LDM guidance.
Perform all other duties as assigned.
Minimum Qualifications
🎓 Education:
University/College degree in Life Sciences, Health Sciences, IT, or related subjects, or certification in allied health professions from an accredited institution.
Relevant and equivalent experience may be considered in lieu of formal education.
🗣️ Language Skills:
Fluent in English (written and verbal).
💡 Skills & Competencies:
Strong organizational, planning, and critical-thinking skills
Effective, engaging communication skills (written and verbal)
Ability to handle multiple tasks in a timely and professional manner
Technical proficiency with Microsoft Office Suite
Ability to maintain confidentiality of data
Understanding of ICH-GCP principles
Experience Requirements
Minimum 3 years of experience in pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, or an equivalent combination of education and experience.
Basic understanding of medical terminology is a plus.
Ability to work in flexible shifts as per business requirements.
Physical Demands / Work Environment
General or remote office setting
Extended periods of sitting at a monitor
Ability to manage multiple priorities and interruptions
Flexible work hours as needed
Equal Opportunity & Accommodation
Fortrea is an Equal Opportunity Employer, committed to providing reasonable accommodations to qualified individuals.
📎 Learn more about EEO & Accommodations [here].
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