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 adherence to departmental SOPs, global standards, and regulatory guidelines to maintain data integrity and consistency across projects.
Key Responsibilities
Data Review & Management
Verify that electronic vendor data includes all protocol-specified parameters, is correctly formatted, and accurately mapped to the appropriate fields and patients.
Review data discrepancies identified by study-specific edit checks and manage the subsequent query resolution process.
Support the LDM in validating electronically transmitted data samples before loading into the database.
Assist in reviewing External Data edit checks, data status reports, and listings.
Vendor & Laboratory Coordination
Support the LDM in developing Data Transfer Agreements and Data Transfer Specifications for vendor data transfers.
Obtain and verify local laboratory normal ranges from all sites, ensuring accuracy and maintaining documentation.
Enter and perform QC of local lab normal ranges; ensure they are correctly linked to patient results.
Assist LDM in communicating data transfer or validation issues to vendors and clients under supervision.
Compliance & Documentation
Ensure data handling adheres to ICH-GCP, company SOPs, and global data standards.
Maintain strict confidentiality of sensitive data and documents.
Support audit readiness and data integrity initiatives as required.
General Duties
Collaborate with clinical staff (CTM/CRA) and other cross-functional teams.
Perform additional tasks or project-related duties as assigned.
Qualifications
Education (Minimum Required)
Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or a related discipline.
Certification in allied health professions from an accredited institution may be considered.
Equivalent experience may be accepted in lieu of formal education.
Experience (Minimum Required)
Minimum 3 years of experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trials industry.
Familiarity with medical terminology is an advantage.
Strong organizational, analytical, and communication skills.
Proficiency with Microsoft Office Suite and technical aptitude for handling data systems.
Ability to multitask, manage priorities, and meet deadlines under pressure.
Understanding of ICH-GCP principles.
Work Environment & Physical Demands
Work performed in an office or remote setting.
Extended periods of sitting and computer use.
Frequent interruptions and shifting priorities.
Must be able to manage multiple concurrent tasks efficiently.
Flexibility to work in shifts as per business requirements.
Equal Opportunity
Fortrea is an Equal Opportunity Employer. Learn more about our EEO & Accommodations request here.
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