- BeiGene (San Mateo, 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
- Takeda Pharmaceuticals (Sacramento, CA)
- …company to inspire you and empower you to shine? Join us as a Senior Manager , Integrated Clinical Trial Data Process Excellence and Delivery based remotely ... be a necessary contributor to our inspiring, bold mission. **_GOALS:_** + The Senior Manager , Process Excellence and Delivery supports the strategy to develop… more
- Takeda Pharmaceuticals (Sacramento, CA)
- …true to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high quality ... - to ensure they meet obligations as described in ICH- GCP and Takeda's Scope of Work, maximize effectiveness and...Scope of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides and… more
- BeiGene (San Mateo, 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 (San Mateo, 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
- MicroVention, Inc. (Aliso Viejo, CA)
- …**Title:** Sr. Manager , Clinical Data Management **Job Description:** The Senior Manager , CDM oversees clinical data management activities across multiple ... FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP /ICH compliance for data management, database operations, clinical report writing, case report… more