- BeOne Medicines (Emeryville, CA)
- …of clinical study processes + Able to independently lead large and/or complex global clinical studies + 5 or more years of progressive experience in ... timelines and budget + Leads all aspects of assigned clinical study (ies) + Leads global ...over the study life cycle + Ensures clinical studies at a project level are… more
- BeOne Medicines (Emeryville, CA)
- …provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional ... 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… more
- BeOne Medicines (Emeryville, CA)
- …provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional ... Clinical Study Report in collaboration with Global Clinical Study Manager...and the quality of the work performed on assigned studies + Contributes to development, optimization and review of… more
- BeOne Medicines (Emeryville, CA)
- …Head will lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated Franchise(s)- ... efficient study planning and execution of associated clinical programs/ studies + Conduct regular program review...and lead efforts to deepen scientific knowledge within the Clinical Operations' function + Champions a global … more
- Edwards Lifesciences (San Francisco, CA)
- …is responsible for providing scientific expertise throughout the development and implementation of clinical studies and clinical evaluations for a dynamic ... clinical science and medical writing deliverables. + Lead clinical study design and clinical ...and accurate data reporting. + Summarize key data from clinical studies and published literature and provide… more
- IQVIA (San Francisco, CA)
- …with all necessary equipment provided._ **What You'll Do** + Lead data management for complex, global clinical trials from study setup to database lock. + ... Management Leads to oversee end-to-end data management delivery for global clinical trials. You'll ensure quality, accuracy,...Management Project Manager_ . + Proven success managing large global studies (1000+ patients). + Expertise with… more
- BeOne Medicines (Emeryville, CA)
- …_Line management responsibilities:_ + Provides leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio ... external stakeholders within the region as well as with global stakeholders to ensure the needs of the business...of the business are met. + Contributes to overall Clinical Operations strategy for the region and is accountable… more
- BeOne Medicines (Emeryville, CA)
- …to planning, label development, label & pack, and distribution for one or more clinical studies . Actively develops and oversees supply plans to ensure accurate ... provides leadership and guidance during process implementations. **Essential Functions:** + Represent the Clinical Supply Chain on Clinical Study Teams (CST)… more
- BeOne Medicines (Emeryville, CA)
- …successful study management **Supervisory Responsibilities:** + Demonstrates knowledge of global clinical trials and the drug development process. + ... **General Description:** The Manager of Clinical Supply Chain manages...for the future. **Essential Functions** : + Represent the Clinical Supply Chain on Clinical Study… more
- IQVIA (Berkeley, CA)
- … Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance ... 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.; * May attend site visits as applicable in… more
- BeOne Medicines (Emeryville, CA)
- …Lead and depot PM setting up distribution and return/destruction procedures for studies following the logistics related procedures. + Coordinate drug destruction at ... internal audit and external audit as needed on logistics data preparation per study or compound level. + Facilitate and coordinate with courier and depot vendors… more
- BeOne Medicines (Emeryville, CA)
- …The primary focus will be on services and products to support our clinical and commercial studies & products including small molecule manufacturing, large ... **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing,...Pharmaceutical Ingredients related CMOs. This role will reside in Global Tech Ops Procurement to establish standard business processes… more
- Abbott (Alameda, CA)
- …clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager / Study Lead as needed. + Proactively and ... monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH...effectively communicate the status of clinical studies to management. + Participate in… more
- BeOne Medicines (Emeryville, CA)
- …with general and study -specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review ... responsible for the management and oversight of their assigned clinical study sites to ensure data quality...minimum of 3-4 years of monitoring experience. Experience in global oncology trials preferred. All qualified applicants will receive… more
- BeOne Medicines (Emeryville, CA)
- …role in the establishment and growth of Clinical Development team as a Global Clinical development team leader. This leader must be a thoughtful and ... mentoring manager , responsible for hiring, training, developing, and retaining talent....to various internal governance committees. + Provides leadership and clinical oversight across all assigned studies and… more
- BeOne Medicines (Emeryville, CA)
- …strategy for a single asset across its entire life cycle - from early clinical development to late-stage pivotal studies , then through commercial launch and ... Ensures cross functional strategic input is embedded in the clinical development plans and regulatory strategy including trial design,...GPT and supports the product strategy. + Partners with Global Program Manager assigned to GPT to… more
- BeOne Medicines (Emeryville, CA)
- …Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members * Support the authoring of ... General Description: The Manager , Safety Scientist supports assigned compounds in conjunction...making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence… more
- Rhythm Pharmaceuticals (San Francisco, CA)
- …(RGDO) and at times support the clinical development team on enrollment of clinical studies . The role is ideal for candidates with strong rare or endocrine ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the...including clinical operations and MSLs, to optimize clinical study recruitment when needed. + Ensure… more
- Edwards Lifesciences (San Francisco, CA)
- …how life-saving data is created, shared, understood, and applied across the global medical community. Aortic stenosis impacts millions of people globally, yet it ... Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical… more
- BeOne Medicines (Emeryville, CA)
- …is responsible for the development of patient safety narratives for Phase 1-4 clinical trials in accordance with the client's controlled processes based on data ... by the client. + Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness.… more