- BeiGene (San Mateo, CA)
- …orders, for clinical trial operations **Planning/Leading:** + Supports COM with clinical trial management ; ensures that clinical trials are ... The Associate Director (AD) Clinical Study Management leads both indirect...contracts and/or work order changes prior to submission to senior management for approval. The AD CSM… more
- Stryker (Fremont, CA)
- …guidelines. + Guides Clinical employees in support of following clinical trial management processes and procedures. Allocates/re-allocates internal ... With the clinical project team, collaboratively develop trial protocol, case report form, complaint management ... objectives. + Conducts briefings and technical meetings for senior management and clinical investigators… more
- Gilead Sciences, Inc. (Foster City, CA)
- …following:** + Tracks and prepares program specific information and status updates utilizing clinical trial management system, databases, and tools + ... development programs. ClinOps team ensures effective design, implementation, and management of global clinical trials covering all...reviews and participates in the quality assurance of the clinical trial data or documents + Provide… more
- BeiGene (San Mateo, CA)
- …or healthcare discipline with minimum of 8+ years of combined experience in Feasibility, Clinical Trial Management , Personnel Management and Operations ... and tactical/operational plans aligned to commercial and regulatory objectives + Clinical trial patient and investigator recruitment and retention experience… more
- BeiGene (San Mateo, CA)
- … site budget development and investigator grants budget forecasting. + Familiarity with Clinical Trial Management Systems (CTMS) and financial modules. ... + Collaboration tools (eg, Slack, Microsoft Teams, SharePoint) + Familiarity with Clinical Trial Management Systems (CTMS) **Other Qualifications:** Fluent… more
- Stanford University (Stanford, CA)
- …QUALIFICATIONS:** + Demonstrated excellent communication skills in speaking and writing. + Multisite clinical trial management experience. + Some project ... business development managers. You will collaborate closely with the senior research manager, CEC, to train staff and ensure...management experience. + 2-4 years of clinical research experience is a plus. + Comfortable working… more
- AbbVie (South San Francisco, CA)
- …has established and expanded core capabilities in Precision Medicine (PMed), encompassing clinical trial management , translational medicine and companion ... (Ph.D.), 4-9+ (MS), or 6-12+ (BS) years of project management , clinical trial experience and...Biomarker Program Manager II, Biomarker Program Manager III, or Senior Biomarker Program Manager. Additional Information Applicable only to… more
- BeiGene (San Mateo, CA)
- …+ Experience working and communicating within cross-functional teams + Knowledge of overall clinical trial management process, understanding of the protocol ... the pharmaceutical industry + Prior experience deploying risk-based quality management programs across clinical development preferred +...and other clinical trial related plans and documents + Critical thinking and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description** **POSITION OVERVIEW:** You will typically lead multiple components of clinical trial programs in IBD/inflammation clinical development. ... For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not… more
- Gilead Sciences, Inc. (Foster City, CA)
- …may act as a Clinical Development Lead and Physician Responsible on clinical trial programs in the Inflammation and Fibrosis therapeutic area. Clinical ... This person will interact closely with the therapeutic area's senior management team. **EXAMPLE RESPONSIBILITIES:** + Integrates...assigned products + Leads or otherwise oversees and directs clinical trial protocol design and clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical ... + Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring. + Uses a variety of advanced statistical software,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license ... their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director, Biologics Drug Product MSAT** Gilead Sciences, Inc. is a… more
- BeiGene (San Mateo, CA)
- …ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present ... within the organization. **Significant Contacts** + Interacts with BeiGene employees and senior management . + Interacts with external business partners and… more
- BeiGene (San Mateo, CA)
- …a scientific or healthcare discipline with 12+ years' experience in clinical trial industry + Both Project and Program management experience across the ... management experience is required, including 3+ years of leadership and people management experience at managing senior manager level above persons, and… more
- BeiGene (San Mateo, CA)
- …in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents ... knowledge and expertise **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through… more
- BeiGene (San Mateo, CA)
- …clinical protocol + Provide scientific and medical support throughout conduct of a clinical trial ; respond to clinical questions from sites, IRBs/IECs, ... The Senior Director, Clinical I/O Development will...Health Authorities, and CROs + Review, query, and analyze clinical trial data + Interpret, and present… more
- BeiGene (San Mateo, CA)
- …clinical protocol + Provide scientific and medical support throughout conduct of a clinical trial ; respond to clinical questions from sites, IRBs/IECs, ... The Senior Director, Clinical Development, Solid Tumors...Health Authorities, and CROs + Review, query, and analyze clinical trial data + Interpret, and present… more
- BeiGene (San Mateo, CA)
- …clinical protocol + Provide scientific and medical support throughout conduct of a clinical trial ; respond to clinical questions from sites, IRBs/IECs, ... **General** **Description:** The Senior Director, Clinical Science will support...Health Authorities, and CROs + Review, query, and analyze clinical trial data + Interpret, and present… more
- BeiGene (San Mateo, CA)
- …industry CTMS and data management systems **Other Qualifications:** * Understands clinical trial processes with a thorough knowledge of ICH and associated ... primarily a site monitor and is responsible for the management and oversight of their assigned clinical ...collection is met per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and … more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Senior Manager, Global Clinical Supply Chain KEY RESPONSIBILITIES: ... Senior Manager, Global Clinical Supply Chain is a leader that who carries...problems. The position has end-to-end leadership and accountability for clinical supply management . Prioritizes and creates executable… more