Job Title: Clinical Data Coordinator - I
Job ID: 254474
Category: Clinical
Location: Mumbai, India
Work Environment: General or remote office setting
Role Summary
Supports the Lead Data Manager (LDM) in reviewing, maintaining, and updating external vendor data from central or local laboratories. Ensures compliance with departmental SOPs, guidelines, and global standards to maintain data integrity and consistency across clinical projects.
Primary Responsibilities
Ensure electronic vendor data contains all protocol-specified parameters, correct format, and proper patient mapping.
Support LDM in developing Data Transfer Agreements and Data Transfer Specifications for vendor data transfers.
Review data discrepancies generated by study-specific edit checks for external data and manage query resolution.
Support validation review of electronically transmitted data for a sample of patients for loading purposes.
Assist in reviewing external data edit checks, status reports, and data listings.
Interact with clinical staff (CTM/CRA) to obtain local laboratory normal ranges and resolve discrepancies.
Enter and perform QC for local laboratory normal ranges, ensuring proper attachment to patient results.
Support LDM in communicating with vendors and clients regarding data transfer, validation, or data point issues.
Perform other duties as needed or assigned.
Minimum Required Qualifications
University/college degree in Life Sciences, Health Sciences, Information Technology, or related subjects, or certification in allied health professions.
Fluent in English (written and verbal).
Strong organizational, planning, and critical-thinking skills.
Well-polished, inclusive, and engaging communication skills to interact effectively with sponsors and internal colleagues.
Ability to maintain confidentiality and manage multiple priorities under demanding conditions.
Proficiency in Microsoft Office suite.
Understanding of ICH-GCP principles.
Minimum Required Experience
3 years in pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, or equivalent combination of education and experience.
Basic understanding of medical terminology.
Strong technical aptitude and attention to detail.
Ability to work flexible shifts as per business requirements.
Physical Demands
Prolonged sitting in front of a computer monitor.
Ability to handle multiple interruptions and adjust priorities frequently.
Perform tasks in a professional manner under time-sensitive conditions.
Gujarat :
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Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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