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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Manila |Croatia :
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Japan | Saitama |Tokyo :
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