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Typical Accountabilities
As an extended team member for PMB China to perform centralized Dx data quality check:
? Understand Dx data QC and monitoring plan and equivalent documentations prepared on study basis.
? Manage the data receiving from external testing lab on study-basis.
? Check and monitor molecular (PCR/NGS) and/or tissue biomarker (IHC/FISH) testing performance and results according to Dx data QC monitoring plan and applicable logic rules.
? Identify issues of the diagnostic assay conducted at external laboratories, and escalate issues through appropriate route as defined in relative documents.
? Preparation of study-based test summary reports to support AZ PMB representative’s presentation at study team meetings
Essential requirement
? College or Bachelor degree or equivalent experience in a biology/pharma/healcare/device/CRO subject, with understanding of Dx test data.
? Ability to identify data quality issue and escalate for solution,.
? High responsibility, careful and patience on daily work
? Exposure to working within a technically regulated environment.
? Will ensure compliance with local and global company policies for self and colleagues.