- BeiGene (Emeryville, CA)
- …with general and study-specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and ... responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient...regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day… more
- IQVIA (Berkeley, CA)
- …Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research . * Responsible to maintain personal currency documentation for ... need updating and documenting that to the direct line manager or divisional lead * Responsible for maintaining client...office KNOWLEDGE, SKILLS AND ABILITIES: * Thorough knowledge of clinical research process from Phase I through… more
- BeiGene (Emeryville, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:**...+ 6 or more years of progressive experience in clinical research within biotech, pharma or CRO… more
- Abbott (Alameda, CA)
- …monitor their glucose levels with our new sensing technology. **The Opportunity** The Associate Clinical Research III will assist in the clinical execution ... data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively and effectively communicate the… more
- BeiGene (Emeryville, CA)
- Job Summary: The Senior Manager , Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic ... clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. The Manager , or Senior Manager , Medical Writing is also responsible for… more
- BeiGene (Emeryville, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase ... Quality Assurance. This position will be primarily responsible for ensuring research and development activities are conducted in accordance with applicable… more
- BeiGene (Emeryville, CA)
- **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence (Process & Procedure) is responsible for implementing and ... proactive, risk-based, and phase-appropriate approach to Quality Assurance across the Research and Development pipeline. The position is responsible for driving the… more
- Abbott (Alameda, CA)
- …the way people monitor their glucose levels with our new sensing technology. As the ** Senior Brand Manager , MyFreeStyle** , you are a primary owner of creating ... help troubleshoot when deliverability issues arise. + MLR review: Responsible for clinical and regulatory review of marketing assets you own, using the Veeva… more
- IQVIA (Oakland, CA)
- …Pharmacology, Anatomy, and/or Physiology. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to ... to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality...of Data Team Lead (DTL), Program Lead, Customer Site Manager , and/or a leadership role in a specific CDM… more
- IQVIA (Oakland, CA)
- …with coworkers, managers and customers. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the ... to work with minimal supervision, using available resources, eg, functional managers, senior DTLs. + Comprehensive understanding of clinical drug development… more