- Ascendis Pharma (Palo Alto, CA)
- …mark. We are a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as ... CTS Oncology team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis… more
- Gilead Sciences, Inc. (Foster City, CA)
- …authoring clinical study and regulatory documentation and SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior CTM) grade 28 ... Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical Operations is responsible for the worldwide execution of all Phase… more
- Pfizer (San Francisco, CA)
- ROLE SUMMARY The Clinical Trial Transparency and Disclosure Manager ( Senior Manager ) is an integral member of the Medical Writing department. The ... requirements include, but are not limited to, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information Guidance,… more
- BeiGene (San Mateo, CA)
- …quality study timelines and tracks progress towards these + Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial ... Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ) are...evaluation, change control, study closure budget, budget endorsement by senior management + Adheres to clinical study… more
- BeiGene (San Mateo, 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
- Stryker (Fremont, CA)
- …Learn more about our award-winning organization by visiting stryker.com We are seeking a ** Senior Staff Clinical Data Manager ** to join our Stryker Endoscopy ... to prevent future issues. **What you will do** As ** Senior Staff Clinical Data Manager ,**...+ Develop complex status reports, specifications for analysis of clinical trial data for interim and final… more
- Bristol Myers Squibb (Brisbane, CA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function ... + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical... narratives + Provision of information required by Protocol Manager for development of trial budget, CRO… more
- Abbott (Alameda, CA)
- …+ Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. **Preferred Qualifications** + Demonstrated excellence ... working mothers, female executives, and scientists. **The Opportunity** The Senior CRA will assist in the clinical ...management. + Solid understanding and demonstrated experience of the clinical trial process including study design and… more
- BeiGene (San Mateo, CA)
- …+ Create supply and inventory plans and develop production schedules for clinical trial materials. + Monitor schedule adherence of production schedules ... **General Description:** The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and… more
- AbbVie (San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS) ... and reporting standards in support of AbbVie's portfolio of clinical trials and ensuring AbbVie's conformance to CDISC standards...to CDISC. + Review and provide feedback on SDTM Trial Design Domains + Oversee the creation of SDTM… more
- BeiGene (San Mateo, CA)
- …portfolio progress in the region to senior management and Global Clinical Study Manager as required. + Champions high-impact, cross-departmental teams within ... provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers at various levels for assigned portfolio and… more
- Abbott (Alameda, CA)
- …way people monitor their glucose levels with our new sensing technology. The Senior Clinical Data Management Analyst is responsible for performing data ... or medical or research setting is REQUIRED.** The Senior Clinical Data Management Analyst is also...critical to the successful collection, reporting and analysis of clinical trial data as well as the… more
- BeiGene (San Mateo, 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
- 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
- Stanford University (Stanford, CA)
- Senior Program Manager **School of Medicine, Stanford, California, United States** Research Post Date Mar 15, 2024 Requisition # 102567 TheStanford Prevention ... The Hsing Lab is seeking an exceptional, highly motivated, well-organized, and team-oriented Senior Program Manager to join the team. Under the direction of… more
- Abbott (Alameda, CA)
- …monitor their glucose levels with our new sensing technology. **The Opportunity** The Clinical Manager is responsible for managing and meeting the objectives of ... provides ongoing updates, and presents project results to Division senior clinical management. + Assists in the... project. + Provides input and support for planning post- trial clinical activities and product market launch.… more
- Ascendis Pharma (Palo Alto, CA)
- The Senior Manager , Statistical Programmer will be expected to provide timely support to the study team on all programming matters according to project ... approval. This position requires a comprehensive knowledge of CDISC standards, clinical trial study design, and electronic data submission requirements.… 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 (San Mateo, CA)
- …signal detection and signal assessment along with required documentation following BeiGene process ** Clinical Trial Support** + Conduct review of safety data and ... departmental activities **Supervisory Responsibilities:** + The position has no direct reports. The Senior Manager , Safety Scientist is part of a team that… more
- Abbott (Alameda, CA)
- … Clinical Research Associate I you will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical ... 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