- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** The Clinical Manager is responsible for managing and meeting the ... Clinical + Provides input and support for planning post- trial clinical activities and product market launch....+ Expertise with GCPs, and regulatory compliance guidelines for clinical trials (eg applicable ISO Standards, FDA).… more
- BeiGene (Emeryville, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at ... 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
- IQVIA (Berkeley, CA)
- …operates. Req * Requires understanding of project finances. Req * Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill ... At least 2 years of Clinical Trial Management experience Sickle Cell...as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials .… more
- IQVIA (Berkeley, CA)
- …Functionally responsible for all team members throughout the duration of each clinical trial . Assures clear client communication, process documentation, and ... to manage multiple priorities within a variety of complex clinical trials * Ability to reason independently...health-related field with at least five (5) years direct clinical trial experience in a CRO or… 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)
- …required. + Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. + Experience in conducting medical device ... for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively...management. + Solid understanding and demonstrated experience of the clinical trial process including study design and… more
- BeiGene (Emeryville, CA)
- …consistency across the organization + Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other ... degree in a scientific or healthcare discipline with 14+ years' experience in clinical trial industry + Both Project and Program management experience across… more
- Edwards Lifesciences (Walnut Creek, CA)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more
- BeiGene (Emeryville, CA)
- …Data Management, and other BeiGene Research Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for ... procedures, and external regulatory requirements. Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.… more
- BeiGene (Emeryville, CA)
- …job:** + Under minimal guidance, responsible for the development of Japan and ROW clinical trial budgets leveraging Japan point system and FMV (for ROW) ... **General Description:** The Manager of Budget Development for Japan and ROW...determine budget line-item costs. Responsibilities include partnering with Global Clinical Operations (GCO), Investigator Contracts Management (ICM), and Data… more
- BeiGene (Emeryville, CA)
- …minimal guidance, responsible for the development of global and region/country specific clinical trial budgets leveraging FMV benchmarking tool and established ... **General Description:** The Manager of Budget Development works independently and collaboratively...and site budget development. This position partners with Global Clinical Operations (GCO), Investigator Contracts Management (ICM), and Data… more
- BeiGene (Emeryville, CA)
- …in collaboration with Safety Science team members and relevant cross-functional team members ** Clinical Trial Support** + Lead the review of safety data and ... specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related...monitor the safety of patients on allocated clinical trials + Lead the writing and… more
- BeiGene (Emeryville, CA)
- …CMC experience with proven record of experience in global submissions for clinical trial /marketing applications and subsequent response to HA queries. + ... product lifecycle for assigned projects. + Provide regulatory CMC review of clinical protocols and investigator brochures, etc. for assigned projects. + Provide… 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