- BeiGene (Emeryville, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase ... deficiencies to senior management, as appropriate + Support and manage GCP Quality investigations + Coordinate and/or administer GCP training, as needed… more
- BeiGene (Emeryville, CA)
- …in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the ... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues...GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point… more
- BeiGene (Emeryville, CA)
- …study sites to ensure data quality and patient safety in accordance with ICH- GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the ... study-specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks… more