Clinical Data Coordinator I
Location: Bangalore
Employment Type: Full Time
Posted On: Yesterday
Application Deadline: July 31, 2026
Job Requisition ID: 26721
Job Overview
May support the Lead Data Manager (LDM) with the review, maintenance, and update of External Vendor data received from central vendors or local laboratories. Responsible for ensuring departmental SOPs, guidelines, and global standards are followed to maintain data integrity and consistency across all projects.
Summary of Responsibilities
Ensure electronic vendor data contains all protocol-specified parameters, is in the correct format, and populates specified fields and patient records accurately.
Support the LDM in the development of Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) for vendor data transfers.
Review data discrepancies generated through study-specific edit checks for external data and manage the query resolution process.
Support validation reviews of electronically transmitted data for selected patient samples before data loading.
Assist in reviewing External Data edit checks, status reports, and data listings.
Coordinate with Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) to obtain local laboratory normal ranges for all study sites.
Research and resolve discrepancies related to laboratory normal ranges and maintain appropriate documentation.
Enter and perform Quality Control (QC) checks on local laboratory normal ranges.
Verify that laboratory normal ranges are correctly linked to patient results within the local laboratory data collection module.
Communicate vendor and client issues related to data transfers, validation issues, and data discrepancies under the supervision of EDS II or above.
Perform other duties as assigned.
Qualifications (Minimum Required)
Bachelor's degree in Life Sciences, Health Sciences, Information Technology, or a related field.
Certification in allied health professions from an accredited institution may also be considered.
Relevant and equivalent work experience may be accepted in lieu of educational qualifications.
Fluent in English (both written and verbal).
Experience (Minimum Required)
Minimum 3 years of experience in:
Pharmaceutical Industry
Biotechnology Industry
Medical Devices/Diagnostics Industry
Clinical Research/Clinical Trials Industry
Preferred Skills and Knowledge
Basic understanding of medical terminology.
Strong organizational, planning, and critical-thinking abilities.
Excellent written and verbal communication skills.
Ability to manage multiple tasks and priorities effectively.
Proficiency in Microsoft Office Suite.
Strong technical aptitude.
Ability to maintain confidentiality of sensitive data.
Understanding of ICH-GCP (International Council for Harmonisation – Good Clinical Practice) guidelines.
Physical Demands / Work Environment
Work in a general office or remote office environment.
Sit for extended periods while working on a computer.
Handle multiple interruptions and shifting priorities.
Manage multiple responsibilities simultaneously.
Willingness to work flexible shifts based on business requirements.
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