岗位职责:
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
任职要求:
•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.