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Clinical Data Coordinator -I

3+ years
Not Disclosed
10 Oct. 31, 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

Position: Clinical Data Coordinator – I

Location: Mumbai, India
Category: Clinical
Job ID: 254474


Job Overview

The Clinical Data Coordinator – I supports the Lead Data Manager (LDM) in the review, maintenance, and updating of External Vendor Data received from central or local laboratories.
The role ensures adherence to departmental SOPs, guidelines, and global standards to maintain data integrity and ensure consistency across all clinical projects.


Key Responsibilities

  • Review electronic vendor data to ensure:

    • All protocol-specified parameters are included

    • Data is in the correct format and properly mapped to patient fields

  • Support the LDM in developing:

    • Data Transfer Agreements (DTA)

    • Data Transfer Specifications (DTS) for vendor data transfers

  • Review data discrepancies generated by study-specific edit checks for external data and perform query management to resolve data issues

  • Assist LDM in validation review of electronic data for selected patient samples before database loading

  • Support review of:

    • External Data edit checks

    • Status reports and listings

  • Collaborate with Clinical staff (CTM/CRA) to collect local laboratory normal ranges for all study sites

  • Research and resolve discrepancies in lab normal ranges and maintain proper documentation

  • Enter and perform Quality Control (QC) for lab normal ranges and ensure correct attachment to patient results in the local lab data module

  • Assist LDM in communicating with vendors and clients regarding:

    • Data transfer problems

    • Data point issues

    • Validation issues (under supervision of EDS II or above)

  • Perform any additional duties as assigned


Qualifications (Minimum Required)

  • Bachelor’s or Master’s degree in:

    • Life Sciences, Health Sciences, Information Technology, or a related field

    • OR certification in allied health professions from an accredited institution

  • Equivalent experience may be considered in lieu of education

  • Fluent in English (written and verbal)


Experience (Minimum Required)

  • 3 years of prior experience in:

    • Pharmaceutical, Biotechnology, Medical Device/Diagnostics, or Clinical Trial industries

    • Or equivalent combination of education and experience

  • Basic medical terminology knowledge (preferred)

  • Strong organizational, planning, and analytical skills

  • Excellent verbal and written communication for interaction with sponsors and internal teams

  • Ability to multitask effectively under demanding conditions

  • Proficiency in Microsoft Office Suite

  • Strong technical aptitude

  • Ability to maintain data confidentiality

  • Understanding of ICH-GCP principles


Work Environment & Physical Demands

  • Office-based or remote working environment

  • Prolonged sitting in front of a computer monitor

  • Frequent interruptions and priority adjustments

  • Ability to manage multiple priorities simultaneously

  • Willingness to work flexible shifts as per business needs


Equal Employment Opportunity

Fortrea is an equal opportunity employer.
Accommodations for applicants with disabilities are available upon request during the recruitment process.

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