- Gilead Sciences, Inc. (Foster City, CA)
- …to adjust workload based upon changing priorities + Meets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency. ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance… more
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …out leadership vision and directions while providing expertise for Gilead's global clinical trials . Works collaboratively within the department and with cross ... Join Gilead and help create possible, together. **Job Description** ** Manager , Global Clinical Supply Chain** **KEY RESPONSIBILITIES:**...with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.… more
- ThermoFisher Scientific (San Francisco, CA)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… 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 ... scientific or healthcare discipline with 12+ years' experience in clinical trial industry + Both Project and...years of leadership and people management experience at managing senior manager level above persons, and experience… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager , Biostatistics - Clinical Drug Dev - ... technical and operational statistical activities for a group of clinical trials . + Is a point of...through management of internal and external resources. + Provides senior level review of various technical documents. + Excellent… more
- Kelly Services (South San Francisco, CA)
- …+ CRO Management + Google Cloud Platform (GCP) + Good Clinical Practice (GCP) + Clinical Trials + SharePoint + Trial Management + Industry standards + ... a pivotal part in the successful execution of their clinical trials and oversight of investigative site...strong relationships with site staff and stakeholders. **KEY RESPONSIBILITIES** Clinical Trial Management: + Oversee and monitor… more
- BeiGene (Emeryville, CA)
- …performing variance analysis between budgets created at the various stages for our clinical trials . The Manager interacts interdepartmentally with Global R&D ... Pricing serves as a subject matter expert in the clinical trial site budgeting, benchmarking, and pricing...cost budget estimates and scenario modeling for BeiGene sponsored clinical trials (BEST). This position will drive… more
- AbbVie (South San Francisco, CA)
- …submissions to health authorities (HAs), including Investigational New Drug (IND)/ Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure ... to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European… more
- Edwards Lifesciences (Oakland, CA)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... us and be part of our inspiring journey. As ** Senior Manager , Biostatistics, TMTT** , you will...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more
- Catalent Pharma Solutions (South San Francisco, CA)
- ** Senior Manager , Global Process Owner, Order...sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... for Highly Potent Active Pharmaceutical Ingredients (https://www.catalent.com/oral-dose/highly-potent-active-pharmaceutical-ingredients/) . The ** Senior Manager , Global Process Owner, Order to… more
- BeiGene (Emeryville, CA)
- …Experience working and communicating within cross-functional teams + Knowledge of overall clinical trial management process, understanding of the protocol and ... other clinical trial related plans and documents + Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk… more
- AbbVie (San Francisco, CA)
- … clinical trials , patient safety, and global medical affairs. The Senior Manager works independently in partnership with experts in multiple disciplines ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Statistics provides statistical leadership to support the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** ** Senior Manager , Statistical Programming (Oncology)** **Job Responsibilities and ... skills are required. + Has a thorough understanding of clinical trials design and reporting process, as...timeframe. + Viewed as a key resource by more senior individuals on technical initiatives and may represent the… 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. + ... mitigation activities needed throughout product life cycle. Escalate critical issues to senior management. + Lead or contribute to development of internal regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …planned and manufactured batches/lots, suppliers/vendors, assets (computer systems, instruments, equipment), clinical trials , etc. This data is leveraged for ... associations to QMS records like Deviations, metadata on documents, and for integration with regulatory systems and SAP ERP, so it is important that it is curated, consistent and of the highest quality and accuracy. **Responsibilities:** + As part of the… 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
- Medtronic (San Francisco, CA)
- …+ Manage and direct the daily operations of the Therapy Development team for clinical trial case support, executing on the strategies outlined by the Director, ... compassionate world. **A Day in the Life** The Regional Manager supports the Therapy Development team of TDMs and...with a cross functional team including Research and Development, Clinical , Quality, and others to ensure therapy adoption by… more