What You Will Do
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In this vital role, you will be responsible for managing and maintaining laboratory reference ranges in the Electronic Data Capture (EDC) system. This includes reviewing local and central laboratory documents, providing subject matter expertise on lab data, and entering validated reference ranges into the system. You will also work to identify and resolve discrepancies, ensuring accurate and standardized laboratory data across global clinical studies.
Key Responsibilities
- Approve new lab parameters, units, and textbook ranges as per protocol and scientific standards.
- Serve as a subject matter expert (SME) for laboratory data and clinical reference ranges.
- Review local and central laboratory reference range documentation for accuracy and completeness.
- Create Lab IDs and enter respective ranges and units into the EDC system for each lab analyst.
- Identify inconsistencies and help resolve discrepancies in local lab reference ranges.
- Escalate and communicate daily operational issues and risks.
- Participate in Data Management (DM) and **cross-functional