- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director, Global Clinical Supply Chain** Senior ... practices and experience working with a GxP environment. The Senior Director, Global Clinical Supply...with internal and external stakeholders. + Possesses experience with clinical blinding practices in global study… more
- BeOne Medicines (Emeryville, CA)
- …and resolution of GMP and GDP compliance matters. This role reports to the Senior Director, Global Clinical Operations Compliance Lead. **Essential Functions ... **General Description:** The Director Global Clinical Supply Compliance builds, collaborates...and implementation of risk identification and management strategy for clinical studies and other regulated drug development… more
- Actalent (San Francisco, CA)
- Job Title: Senior Clinical Study Manager...or higher. + Experience leading Phase II or III global studies within oncology + Experience working ... The Senior Clinical Study Manager is responsible for ensuring the successful execution... studies . Responsibilities + Lead the development of clinical study plans, identifying critical path activities… more
- GRAIL (Menlo Park, CA)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and data science to ... companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead...management activities for one or multiple diagnostic product development studies in support of GRAIL's robust clinical … more
- BeOne Medicines (Emeryville, CA)
- …clear potential to apply their existing skills to oncology. + Expert understanding of global clinical study design and drug development process from ... amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and...functional areas for the successful implementation and execution of clinical studies . + Provide scientific expertise for… more
- BeOne Medicines (Emeryville, 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
- Medtronic (San Francisco, CA)
- …a Principal Field Clinical Specialist, you will provide day-to-day field clinical study support, technical and education support, and site management, ... or solution. + All other duties as assigned. **Technical Role** + Assist in the clinical study procedure, playing a key role in all aspects of Intrepid TMVR/TTVR… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help ... and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access. This role will… more
- Actalent (San Francisco, CA)
- …+ 7+ years of clinical trial management experience. + Experience with global study management (Any Phase I-III). + Vendor/CRO management and oversight. + ... Operations Job Description Align with the Head of Clinical Development Operations or Senior Director, ...appropriate innovative and best-in-class procedures and SOPs related to clinical study oversight and execution. + Work… more
- BeOne Medicines (Emeryville, CA)
- …responsible to implement the GCO digital strategy with the goal to increase Global Clinical Operations' productivity and reduce clinical trial ... **General Description:** The Senior Manager, Digital Clinical Operations Solutions...Manage the implementation of GCO technology roadmap to increase Global Clinical Operations' productivity, reduce rising costs… more
- Abbott (Alameda, CA)
- …. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality ... you'll do:** + Conduct single or multi-center medical device clinical studies . + Perform study ...procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning study conduct, designing… more
- Bristol Myers Squibb (Brisbane, CA)
- … lifecycle ** Clinical Development Expertise & Strategy** + Designs and develops clinical studies and research plans in support of asset strategy with the ... their personal lives. Read more: careers.bms.com/working-with-us . The Early Clinical Development function is part of a global...Early Clinical Development Leadership team; clinical … more
- Abbott (Alameda, CA)
- …shipping study devices and supplies to clinical sites. + Perform study device accountability and reconciliation. + Assist senior staff in development of ... study -specific forms and trial-specific monitoring plans. + Assist senior staff in study planning, designing case...needed. + Proactively and effectively communicate the status of clinical studies to management. + Participate in… more
- Abbott (Alameda, CA)
- …shipping study devices and supplies to clinical sites. + Perform study device accountability and reconciliation. + Assist senior staff in development of ... study -specific forms and trial-specific monitoring plans. + Assist senior staff in study planning, designing case...needed. + Proactively and effectively communicate the status of clinical studies to management. + Participate in… more
- Bristol Myers Squibb (Brisbane, CA)
- … lifecycle. ** Clinical Development Expertise & Strategy** + Designs and develops clinical studies and research plans in support of asset strategy with the ... Early Clinical Development Leadership team; Clinical ...initiatives (eg, committees, sub-teams etc.) + Presents and/or articulates clinical strategy to senior leadership and to… more
- BeOne Medicines (Emeryville, CA)
- …Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines ... studies , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of...to accelerate study execution. + Partners with global clinical program leaders and development core… more
- Actalent (Foster City, CA)
- …specifications, including statistical analysis plans (SAPs) . Draft and review observational study reports . Conduct observational studies , both primary data ... collection and secondary data use studies . Conduct study data analysis according...and management * Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions… more
- Ascendis Pharma (Palo Alto, CA)
- …Programming, will be expected to provide timely and strategic programming support to clinical study teams in alignment with project goals. This role combines ... and specification templates of SDTM and ADaM used across clinical studies . This position requires expertise in...Generate or validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions.… more
- Kelly Services (South San Francisco, CA)
- …and execution of clinical research studies and review key clinical documents (eg, protocols, clinical study reports, regulatory submissions). * ... **Kelly(R) Science & Clinical ** is seeking a Senior Medical...clinical research sites and CROs, MM of the clinical studies , initial safety review of adverse… more
- AbbVie (San Francisco, CA)
- …Events (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies . + Leads the development and execution of advisory boards, ... to support global business strategy. + Proven ability to run a clinical study or medical affairs cross-functional team independently. + Knowledge of … more