We interpreted Mountain View, CA as Mountain View, CA. Other options include: Mountain View (Contra Costa County), CA
- BeiGene (San Mateo, CA)
- …updates on portfolio progress in the region to senior management and Global Clinical Study Manager as required. + Champions high-impact, ... team, provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers at various levels for assigned… more
- BeiGene (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study ... and budget + Acts as regional lead for multiple studies across an indication or across a program as...Clinical Study Report in collaboration with Global Clinical Study Manager and… more
- BeiGene (San Mateo, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads or co-lead aspects of a… more
- Stryker (Fremont, CA)
- …We are seeking a ** Senior Staff Clinical ... to prevent future issues. **What you will do** As ** Senior Staff Clinical Data Manager,** you will...local procedures. + Train internal and external collaborators in study specific clinical data management processes, the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manage Gilead's investigator externally sponsored research program in HIV, and serve as Gilead study lead for key interventional Phase 4 studies in HIV treatment ... affairs global lead for Gilead Sponsored and collaborative research studies + Provide high quality technical and methodological support to cross-functional teams… more
- Danaher Corporation (Sunnyvale, CA)
- …have oversight for clinical strategy, protocol development and clinical study reports for US and OUS registration studies . + Prepare scientific content ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Clinical Research Scientist develops and independently… more
- BeiGene (San Mateo, CA)
- …a site monitor and is responsible for the management and oversight of their assigned clinical 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 Clinical Study Teams (CSTs) by supporting day to day clinical … more
- Abbott (Santa Clara, CA)
- …applications and submissions. + Reviews IFUs, patient guides, Risk Management files, clinical study reports, physician training materials, ensuring alignment of ... + Understanding of regulations, standards and guidelines related to medical devices clinical studies , and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... experience managing direct reports. + Meets all requirements for Senior Clinical Trial Manager ( Senior ... studies . + Proven ability to effectively author clinical study documentation. + Functional expertise to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior ... studies . + Proven ability to effectively author clinical study and regulatory documentation. + Ability… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Quality is seeking a Senior Director, Inflammation TA Lead to join our Clinical Quality Business Partners Leadership Team. In this role you will lead and set ... strategy for a global team that provides the GCP quality oversight for...+ Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Operations and… more
- BeiGene (San Mateo, CA)
- …+ Support meetings through safety data interpretation + Review of DMC/SMC materials ** Clinical Study Reports** + Provide additional summary Epi analysis to ... results to support PV activities and Safety Topic Review background **Epidemiologic Studies ** + Design protocols and conduct/contract study execution **Safety PV… more
- Gilead Sciences, Inc. (Foster City, CA)
- … programs and studies . The Director will have experience in global clinical development and operations, innovative thinking, program/ study design ... include the design, development, and delivery of operational strategy ( global study feasibility) and other capabilities within...toward the successful design and execution of Phase I-IV global clinical trials to identify opportunities to… more
- BeiGene (San Mateo, CA)
- …clear potential to apply their existing skills to oncology + Expert understanding of global clinical study design and drug development process from discovery ... partners. The candidate will report to the Vice President, Global Clinical Development. As a leader in...review key documents, including, but not limited to: + Clinical study reports + Abstracts, posters and… more
- Stanford University (Stanford, CA)
- …and epidemiologic studies , including the launch of a new epidemiologic study focused on Asian American health (ARISE) funded by the National Heart, Lung, ... Senior Program Manager **School of Medicine, Stanford, California,...Blood Institute (NHLBI) and other large international cancer consortium studies . The successful candidate will provide leadership and guidance… more
- BeiGene (San Mateo, CA)
- …project timelines. + Contribute to the design and analysis of PK data from patient clinical studies . + Conduct hands-on clinical PK and pharmacometric data ... pharmacology sections of regulatory filings. A working knowledge of global regulatory practices as they relate to clinical...all phases of clinical development. + Develop clinical pharmacology study designs and collaborate with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products + In general, serves ... presentations + Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on… more
- Abbott (Santa Clara, CA)
- … research organization. This position includes providing statistical expertise in clinical study design, writing statistical analysis plans and reports, ... under limited supervision by the statistical manager, provides statistical support to clinical study teams and external teams. This includes: + statistical… more
- J&J Family of Companies (Santa Clara, CA)
- … leadership to ensure that HEMA endpoints are well defined as part of the clinical studies . Working closely with the individual launch markets to assess data and ... for Medtech Surgery, will work in close collaboration with Global Strategic Marketing, Research & Development, Medical, Clinical...clinical and quality of life outcomes data from clinical trials and/or epidemiology studies ; + Supports… more
- Gilead Sciences, Inc. (Foster City, CA)
- …involved with the development and validation of IVDs (eg, Study Management, Clinical , Biomarkers) and presents to senior leadership as required. + Develops, ... vision for the translational discovery, development, and validation of biomarkers in clinical studies . You will provide operational and technical regulatory… more