- BeiGene (San Mateo, 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
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Senior Manager , Global Clinical Supply Chain KEY RESPONSIBILITIES: ... Senior Manager , Global Clinical Supply Chain is a leader that who carries...Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master… more
- BeiGene (San Mateo, 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
- BeiGene (San Mateo, CA)
- …degree in a scientific or healthcare discipline with 12+ years' experience in clinical trial industry + Both Project and Program management experience across ... the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated...years of leadership and people management experience at managing senior manager level above persons, and experience… more
- BeiGene (San Mateo, CA)
- …expertise in data engineering and process improvement with a strong understanding of clinical trial finance, including site payments, site contracts, and budget ... forecasting. The position will work closely with the Senior Manager to implement technical solutions, analyze data, and optimize processes related to… more
- Stanford University (Stanford, CA)
- Senior Program Manager **School of Medicine, Stanford, California, United States** Research Post Date Mar 15, 2024 Requisition # 102567 TheStanford Prevention ... The Hsing Lab is seeking an exceptional, highly motivated, well-organized, and team-oriented Senior Program Manager to join the team. Under the direction of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Manager , Global Clinical Supply Chain** **KEY RESPONSIBILITIES:** Manager ... external partners to resolve shipping related issues. Escalates to senior leadership as needed. + Supports the clinical...Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master… more
- BeiGene (San Mateo, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required. + Oversees the regional study team at internal ... and SOPs as required. + Drives deliverables regionally for trial or portfolio. **Essential Functions of the job:** **Regional... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing. **Quality**… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This **Regulatory Affairs Senior Manager ** position is an onsite opportunity working out of ... and/or Class III medical devices + Experience with IDE trial strategy and post market clinical activities + Ability to define regulatory strategy. Able to… more
- BeiGene (San Mateo, CA)
- …of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing. **Quality** _Line management responsibilities:_ ... regional leadership team, provides strategic leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio and may… more
- BeiGene (San Mateo, CA)
- …continuous monitoring of key operational performance areas. + Identify inefficiencies in clinical trial processes and propose data-driven solutions based on data ... efficiency and effectiveness. + Present findings and recommendations to senior leadership & stakeholders through clear and concise reports... would be a plus. + Solid understanding of clinical trial processes, protocols, and regulations (eg,… more
- Abbott (Pleasanton, CA)
- …as directed by your manager . + Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments ... to restore their health and live full lives. The ** Senior Clinical Research Scientist** is a member...as well as study sites as directed by their manager . **What You'll Work On** + Writes clinical… more
- Stanford University (Stanford, CA)
- …+ Demonstrated excellent communication skills in speaking and writing. + Multisite clinical trial management experience. + Some project management experience. + ... Clinical Events Committee Specialist I **School of Medicine,...business development managers. You will collaborate closely with the senior research manager , CEC, to train staff… more
- BeiGene (San Mateo, CA)
- …ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present ... **General Description:** + The Manager , Regulatory Affairs CMC, is responsible for developing...CTA, BLA, MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in… more
- BeiGene (San Mateo, CA)
- …priorities. + Ensure cross functional strategic input is embedded in the clinical development plans and regulatory strategy including trial design, endpoints, ... strategy for a single asset across its entire life cycle - from clinical development to late-stage pivotal studies, then through commercial launch and market access,… more
- Ascendis Pharma (Palo Alto, CA)
- …colleagues to advance our exciting product pipeline. The Role As our new Senior Manager or Associate Director, Statistical Programming (level commenserate with ... production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission. +… more