Specialist, Local Lab Delivery
Specialist, Local Lab Delivery
Regeneron- Posted 2 hours ago
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Job Description
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
More Info
Key Skills
Oracle Inform
Medidata Rave
laboratory data review
EDC systems
About Company
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Java, Apache Airflow, Git, Informatica, DataFlow, Python, Sql, AWS, GCP Composer, Beam
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Technical Sales, Application Support, Analytical Instruments, Data Analysis, scientific method validation, measurement principles
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Data Management, Ms Excel, Reconciliation, ADP Payrun, timesheet collection, Validation, US payroll concepts
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Test Data Management, Regression Testing, Backend Testing, PostgreSQL, Performance Testing, Spring Boot Microservices, Integration Testing, Postman, Kubernetes, AWS, AI-related Technology Exposure, Microservices Testing, Test Environment Management, Agile Delivery, Test Automation Frameworks, Event-Driven Architectures, Swagger Validation, Service-to-Service Integration Testing, Newman, Security Vulnerability Testing, OpenAPI, API Testing Automation
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IT Asset Management (ITAM), Hardware Asset Management (HAM), Software Asset Management (SAM), Power Bi, Sql, Quality assurance, data stewardship, Data Analysis, Content Management, Content governance, Excel advanced functions, AI-powered tools and technologies, Scripting automation, Content validation