- Astellas Pharma (South San Francisco, CA)
- …relate to nonclinical study design and data analysis Experience drafting non - clinical sections of IND/CTAs **Working Environment** At Astellas we recognize ... our website: www.astellasgenetherapies.com. **The Role** The primary purpose of the Nonclinical Study Manager is to select Contract Research Organizations (CROs)… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Senior Manager , Biostatistics - Virology** United States - **REMOTE** or Foster City, ... to ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Manages all components of small clinical studies , including Phase I studies . * Manages actively clinical study budgets and exercises proactive ... oversight monitoring visits, * Defines study logistics and oversees/ develops clinical study plans for assigned clinical studies . * Manages study … more
- Gilead Sciences, Inc. (Foster City, CA)
- …protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports + Must be able to understand, interpret ... Coordinates review of data listings and preparation of interim/final clinical study reports + Assists in determining...regulations), ICH Guidelines, and GCP governing the conduct of clinical studies + Working knowledge and experience… more
- Pfizer (South San Francisco, CA)
- …and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non -CRF, using an ... staff to deliver high quality data management for all studies as assigned. + Proactively drives quality and efficiency...clinical trials and ability to assess and determine study requirement from protocol review + Strong Project and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …communication skills in a fast-paced, global company **FOCUSE AREAS:** + Interprets clinical study protocols and/or dosing schema. Translates the information to ... and support. + Supports regulatory filings and inspections. + Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …safe delivery of investigational medicinal products (IMP). FOCUS AREAS: + Interprets clinical study protocols and/or dosing schema. Translates the information to ... and support. + Supports regulatory filings and inspections. + Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and… more
- Pfizer (South San Francisco, CA)
- …on Clinical Sub Team and Development Team, as appropriate. + Provides the clinical pharmacology components to Clinical Study Protocols, Clinical ... expertise to oncology project teams including planning, design, and oversight of clinical pharmacology studies with operational assistance from clinical … more
- Bristol Myers Squibb (Brisbane, CA)
- …lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key Responsibilities** + Accountable ... the development of each indication strategy, including registrational and non -registrational studies , with the support of the...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …reporting, etc. **EXAMPLE RESPONSIBILITIES:** + With guidance, acts as biostatistics lead on clinical studies or other non -molecule projects. + Where ... providing statistical consultation on clinical development plans, clinical trial design and clinical study... endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing… more
- AbbVie (South San Francisco, CA)
- …across studies while maintaining AbbVie biomarker standard language and study timelines. Work with non -PMed areas to improve cross-functional processes. ... Expert (SME). + Responsible for relevant biomarker content in clinical study documents and associated systems (including...requirements. May work with or manage a Sample Operations Manager with responsibility for these tasks. + Understand and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Chain is responsible for managing investigational medicinal products (IMP) for Gilead clinical studies . The role works collaboratively within the department and ... advancing the care of patients with life-threatening diseases. **Associate, Global Clinical Supply Chain** **KEY REPONSIBILITIES:** Associate, Global Clinical … more
- Pfizer (South San Francisco, CA)
- …program management operating with highly matrixed teams within health, medical, clinical research/ study operations, life sciences consultancy, or related / ... support regulatory, launch, and post-launch strategy. The IEP Sr Manager is a member of the IEP Success team,...with digital evidence catalog to identify connections between existing studies /analyses with relevance to new IEPs + Maintain working… more
- Stanford Health Care (Pleasanton, CA)
- …culture that focuses on goals, metrics, and continuous improvement, FS&P provides non - clinical operational support to Stanford Health Care and other Stanford ... Medicine entities to ensure safe and successful non - clinical operations 24/7 and plan for the...your chance to join the team as a Facility Manager ! Stanford Health Care Facility Managers provide higher standards… more
- Select Medical (Pleasanton, CA)
- …People Leadership Functions:** + Assist with staff development and growth, offering clinical and non - clinical employees coaching, guidance, training, and ... **Overview** **Physical Therapist - Assistant Center Manager ** **Pleasanton, CA** **Up to $20,000 SIGN ON BONUS** **+** **STUDENT DEBT BENEFIT PROGRAM** Select… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases, investigator's brochures, CTD summaries/overviews, ... have an exciting and unique opportunity for a senior level medical writer (Senior Manager , Medical Writing, Oncology) to join our dynamic team. You will author a… more
- Stanford Health Care (Emeryville, CA)
- …hires. Interviews applicants as part of the panel with Echo Lab manager , recommends hires. Also responsible for generating preliminary interpretation of ultrasound ... echo lab supervisor must conduct and record echocardiographic ultrasound studies based on a physician order, acquire all images...community physicians to advise and recommend the type of study that will achieve appropriate results based on patient… more
- Veterans Affairs, Veterans Health Administration (Martinez, CA)
- …on community and VA resources. Make referrals to a variety of VA and non -VA resources in support of the rehabilitation objectives of the Veteran. Provides services ... behavioral health teams to assure continuity of care by providing consultation regarding clinical needs, plans of care, and care management for Veterans enrolled in… more
- Stanford Health Care (Redwood City, CA)
- …and serves as a resource in meeting those needs. + With the support of the manager , may initiate clinical research within area of clinical expertise. + ... of the patient. The Therapist II serves as a clinical advisor to less experienced Therapists by consulting on...activities, eg chart reviews, revision of documentation forms, workflow studies , etc. + Contributes to the development of departmental… more