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.