30 Oct
|
Regeneron
|
India
Specialist, Local Lab Delivery
We're hiring a Specialist, Local Lab Delivery to support clinical trial data management activities. This role is responsible for maintaining and reviewing local laboratory reference range data, ensuring accuracy, quality, and compliance across clinical studies.
Key Responsibilities:
Manage local laboratory reference range (LNR) documentation and metadata
Review and maintain analytes, units, conversion factors, and lab reference ranges
Configure and support local lab setup within EDC systems
Perform data quality checks and resolve laboratory data discrepancies
Collaborate with Clinical Data Management, Clinical Operations, CROs, and study teams
Support inspection readiness and database lock activities
Requirements:
2+ years of Clinical Data Management experience with Local Lab/LNR experience
Experience in Pharma, Biotech, CRO, or Healthcare industry
Knowledge of EDC systems (e.g., Medidata Rave, Oracle Inform)
Experience with laboratory data review, validation, and quality control
Understanding of GCP/GxP and clinical trial processes
Bachelor's degree in Life Sciences, Health Sciences, Data Management, or related field
📌 Specialist, Local Lab Delivery Secunderabad (India)
🏢 Regeneron
📍 India