- Abbott (Alameda, CA)
- …Communicates with and provides updates to specific core teams. + Oversees activities delegated by Sr . Clinical Research Manager or Sr . Director, ... working mothers, female executives, and scientists. **The Opportunity** The Clinical Manager is responsible for managing and...provides ongoing updates, and presents project results to Division senior clinical management. + Assists in the… 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 ... study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:**… more
- BeiGene (Emeryville, CA)
- …with CRAs to ensure data collection is met per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to ... Familiar with industry CTMS and data management systems **Other Qualifications:** * Understands clinical trial processes with a thorough knowledge of ICH and… more
- Abbott (Alameda, CA)
- …required. + Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. + Experience in conducting medical device ... for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively...management. + Solid understanding and demonstrated experience of the clinical trial process including study design and… more
- BeiGene (Emeryville, CA)
- …consistency across the organization + Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other ... scientific or healthcare discipline with 14+ years' experience in clinical trial industry + Both Project and...years of leadership and people management experience at managing senior manager level above persons, and experience… more
- Edwards Lifesciences (Walnut Creek, CA)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience + The… more
- BeiGene (Emeryville, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase ... knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations + Ensure all logistics are… more
- System One (San Rafael, CA)
- Job Title: Senior Manager - CMC Regulatory Location: Hybrid - Local to San Rafael, CA Type: Contract Description: As a Senior Manager in the Regulatory ... preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for… more
- IQVIA (Oakland, CA)
- …budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management ... of Data Team Lead (DTL), Program Lead, Customer Site Manager , and/or a leadership role in a specific CDM...task (eg, Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and,… more