- BeOne Medicines (Emeryville, CA)
- …of clinical study processes + Able to independently lead large and/or complex global clinical studies + 7 or more years of progressive experience in ... timelines and budget + Leads all aspects of assigned clinical study (ies) + Leads global ...endorsement by senior management + Adheres to clinical study budgeting processes and provides input… more
- BeOne Medicines (Emeryville, 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
- 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 Compliance builds, collaborates and...and implementation of risk identification and management strategy for clinical studies and other regulated drug development… 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
- Taiho Oncology (Pleasanton, CA)
- …NDA/MAA registration documents, and scientific publications. + Analyze and interpret outcome of clinical studies within the global development program(s) + ... it most. This is an exciting opportunity to lead global clinical trials and experience multiple facets...+ Use medical/scientific expertise and strategic thinking to develop clinical development plans (incl. study design and… 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 ... will 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
- 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
- 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
- IQVIA (Oakland, CA)
- … global ) Provide leadership and senior support to DTLs on multiple large global studies /programs of global studies Provide leadership and ... senior support to DTLs on multiple large global studies /programs of global ...Terminology, Pharmacology, Anatomy, and/or Physiology. IQVIA is a leading global provider of clinical research services, commercial… more
- Abbott (Alameda, CA)
- …to ensure the development of state-of-the-art Health Economic and Outcomes Research studies . Key internal customers may include global affiliate MA leads, ... Abbott is a global healthcare leader that helps people live more...to initiate and execute Health Economic analyses, Outcomes Research/RWE studies and Market Access initiatives to maximize and protect… more
- BeOne Medicines (Emeryville, CA)
- …and present data to internal project teams, senior management, and to global health authorities. + Discuss clinical pharmacology & pharmacometric plans to ... all phases of clinical development. + Develop clinical pharmacology study designs and collaborate with...the design and analysis of PK data from patient clinical studies . + Conduct hands-on clinical… more
- BeOne Medicines (Emeryville, CA)
- …limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory strategic ... packages throughout the world and ensures timelines are met including the review global submission documents in support of clinical trials and marketing… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... AND DATABASE ACTIVITES - Works with project team to decide on appropriate study design and statistical methodology - Responsible for comprehensive protocol review -… more
- BeOne Medicines (Emeryville, CA)
- …will provide strategic statistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across all phases of clinical development. This role ... with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to ensure robust study design, insightful data analysis, and… more
- IQVIA (Oakland, CA)
- …to work with minimal supervision, using available resources, eg, functional managers, senior DTLs. + Comprehensive understanding of clinical drug development ... experience. + Previous experience and proven competence in managing study delivery through full DM life cycle (at least...with coworkers, managers and customers. IQVIA is a leading global provider of clinical research services, commercial… more
- BeOne Medicines (Emeryville, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... met, including the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and… more
- Abbott (Pleasanton, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... improve system verification. + Design and conduct system characterization testing and studies . Process, analyze, and present resulting data and conclusions. + Drive… more