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Clinical Data Coordinator -I

3+ years
Not Disclosed
10 Oct. 4, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧪 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