🧪 Clinical Data Coordinator - I
Location: Mumbai, India
Category: Clinical
Job ID: 254474
Company: Fortrea
🎯 Job Overview
The Clinical Data Coordinator - I (CDC-I) supports Lead Data Managers (LDMs) in reviewing, maintaining, and updating External Vendor Data from central or local laboratories. This role ensures adherence to departmental SOPs, global standards, and data integrity practices, maintaining consistency across all assigned clinical projects.
🧠 Key Responsibilities
🔹 Vendor Data Management
Verify electronic vendor data includes all protocol-specified parameters, is in the correct format, and accurately populates to designated fields and patients.
Support LDMs in developing Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) for vendor data transfers.
Conduct data discrepancy reviews using study-specific edit checks and perform query management to resolve data issues.
Assist LDM in validation review of electronically transmitted data for selected patient samples prior to database loading.
🔹 External Data Review
Review External Data edit checks, status reports, and listings to ensure completeness and accuracy.
Collaborate with Clinical staff (CTM/CRA) to collect local laboratory normal ranges for all sites.
Research, resolve, and document discrepancies in normal ranges.
Perform data entry and QC for local lab normal ranges and verify their correct attachment to patient results in the database module.
🔹 Vendor Communication
Support LDMs in vendor and client communication regarding data transfer issues, data point discrepancies, and validation concerns (with initial oversight from EDS II or higher).
🔹 General Duties
Maintain strict data confidentiality during all interactions.
Perform additional duties as assigned to support project and departmental objectives.
🎓 Qualifications
📘 Education
Bachelor’s Degree (Life Sciences, Health Sciences, Information Technology, or related field).
Allied Health Certification from an accredited institution is acceptable.
Equivalent experience may be considered in lieu of a formal degree.
🗣️ Language Proficiency
Fluent English (Written & Verbal).
💼 Experience Requirements
Minimum 3 years of experience in Pharmaceutical, Biotechnology, Medical Device/Diagnostics, or Clinical Trial Industry.
Solid understanding of medical terminology (preferred).
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
Demonstrated organizational, planning, and critical thinking skills.
Strong written and verbal communication for sponsor and team interactions.
Proven ability to manage multiple priorities under tight timelines.
Technical aptitude with attention to accuracy and detail.
Working knowledge of ICH-GCP principles.
🧭 Key Competencies
Data accuracy & integrity focus
Cross-functional collaboration
Time management under pressure
Adaptability and proactive problem-solving
Confidentiality and compliance awareness
🌍 Work Environment & Physical Demands
Work from office or remote setup.
Extended computer use (sitting for sustained periods).
Frequent priority shifts and task interruptions.
Must manage multiple concurrent projects.
Flexibility to work in variable shifts per business needs.
⚖️ Equal Employment Opportunity (EEO)
Fortrea is committed to providing equal opportunities and reasonable accommodations for applicants with disabilities.
🔗 Learn more: EEO & Accommodations Information
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