- BeiGene (Emeryville, 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
- BeiGene (Emeryville, CA)
- … clinical payments to our investigative sites and creating Purchase Orders (POs) for clinical vendors. The Senior Manager partners with Global Clinical ... **General Description:** The Senior Manager works closely with the...grants expenses, accruals, trends, and forecasts under BeOne sponsored clinical trials as clinical investigator… more
- BeiGene (Emeryville, CA)
- **General Description:** The Senior Manager , Digital Clinical Operations Solutions Analyst is responsible to implement the GCO digital strategy with the goal ... Operations' productivity, reduce rising costs of clinical trials , and reduce clinical trial inefficiencies + Monitor, evaluate, and optimize the… more
- BeiGene (Emeryville, 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
- Abbott (Alameda, CA)
- …Participate in cross-functional clinical team(s) in the planning and execution of clinical trials . + Proactively and effectively communicate the status of ... members, peers, and management. + Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical … more
- Abbott (Alameda, CA)
- …of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155. ... senior staff in development of study-specific forms and trial -specific monitoring plans. + Assist senior staff...for completeness and accuracy; and escalate issues to the Clinical Operations Manager /Study Lead as needed. +… more
- Abbott (Alameda, CA)
- …of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155. ... senior staff in development of study-specific forms and trial -specific monitoring plans. *Assist senior staff in...for completeness and accuracy; and escalate issues to the Clinical Operations Manager /Study Lead as needed. *Proactively… more
- BeiGene (Emeryville, CA)
- **_General Description:_** The Senior Manager , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) to conduct signal ... Safety Science team members and relevant cross-functional team members Clinical Trial Support . Conduct review of...**Supervisory Responsibilities:** The position has no direct reports. The Senior Manager , Safety Scientist is part of… more
- BeiGene (Emeryville, CA)
- …Familiar with industry CTMS and data management systems **Other Qualifications:** + Understands clinical trial processes with a thorough knowledge of ICH and ... **General Description:** The AD. CRA Manager provides/supports resourcing strategy and personnel oversight within the Site Management organization The AD. CRA … more
- System One (San Rafael, CA)
- Job Title: Senior Manager - CMC Regulatory Location: Hybrid - Local to San Rafael, CA Type: Contract Description: As a Senior Manager in the Regulatory ... preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for… more
- Abbott (Alameda, CA)
- …- Can lead a team of statisticians and programmers on a particular clinical trial - Can provide formal training to statisticians and non-statisticians ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Sr . Biostatistician** **Working at Abbott** At Abbott, you can do work that… more
- IQVIA (Oakland, CA)
- …budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management ... of Data Team Lead (DTL), Program Lead, Customer Site Manager , and/or a leadership role in a specific CDM...task (eg, Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and,… more