Specialist, Local Lab Delivery

Regeneron Pharmaceuticals, Inc.; Hyderabad; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Specialist, Local Lab Delivery to support clinical trial data management and ensure accuracy of local laboratory reference range data across studies.

You will maintain LNR documentation, review analytes and units, and configure local lab setups within EDC systems, collaborating with CDM, operations, CROs, and study teams to support inspection readiness and database locks.

Qualifikationen

• 2+ years of Clinical Data Management experience with Local Lab/LNR.
• Experience in Pharma, Biotech, CRO, or Healthcare.
• Knowledge of EDC systems (Medidata Rave, Oracle Inform).
• Experience with laboratory data review, validation, and quality control.
• Understanding of GCP/GxP and clinical trial processes.

Aufgaben

• 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

Kenntnisse

CDM experience

LNR knowledge

Attention to detail

Collaboration

Ausbildung

Bachelor's in Life Sciences

Tools

Medidata Rave

Oracle Inform

Jobbeschreibung

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