- 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)
- …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
- Stanford University (Stanford, CA)
- …investigators Dr. Titilola Falasinnu and Dr. Dokyoung Sophia You and/or a Clinical Research Manager . Dr. Falasinnu studies epidemiological inference ... Associate to perform duties related to the coordination of clinical studies . Coordinate moderately complex aspects of...in rheumatology, emphasizing pain, disability, and function. One study involves the use of electronic health records to… more
- Stanford University (Stanford, CA)
- Cancer Clinical Research Manager 2 - GI (Hybrid) **School of Medicine, Stanford, California, United States** Research Post Date Aug 07, 2024 Requisition # 104165 ... ** Clinical Research Manager 2** _Hybrid Work Arrangement_...of demonstrated managerial experience. + Demonstrated disease knowledge / study design experience of studies under purview.… more
- Stanford University (Stanford, CA)
- …investigator and/or manager /supervisor. The CRCA will support federal and non -federal clinical research studies including dermatological and ... Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies The CRCA will coordinate moderately complex aspects of… 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
- Stanford University (Stanford, CA)
- …changing the world of health care in the cancer arena. Reporting to the Network Clinical Research Manager (CRM), the CRC3 will be conversant in the goals, ... + Demonstrated project/program leadership skills. + Demonstrated disease knowledge / study design experience of studies under purview. **CERTIFICATIONS &… more
- Pfizer (South San Francisco, CA)
- **ROLE SUMMARY** The Late-Stage Clinical Scientist ( non -MD, Senior Manager ) is responsible for scientific oversight, data integrity and quality of ... informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical … more
- Stanford University (Stanford, CA)
- …for Allergy and Asthma Research. Under the direction of the Medical Director, Clinical Director and Center Manager for Clinical Research, responsibilities ... tests, prepare and maintain source documentation for phase 1-3 studies implemented at the Center, participate in study...budget projections, and staffing needs. + Supervise and train non - clinical and clinical staff/students,… more
- Stanford University (Stanford, CA)
- … staff, researchers, outside vendors, and other staff to administer treatment and study protocols. May coordinate multi-site studies . * Conduct study ... Nurse who, under the direction of the CTRU Nurse Manager , will apply medical knowledge and experience to implement...information (written and verbal). * Ability to implement good clinical practices in all interactions with study … more
- Stanford University (Stanford, CA)
- …implementation + Comprehensive understanding of scientific principles, especially regarding epidemiological studies , clinical research, and clinical trials. ... Research Data Manager **School of Medicine, Stanford, California, United States**...ideal incumbent will understand the big picture of our clinical research program, implement tools to achieve program goals,… more
- Stanford University (Stanford, CA)
- … staff, researchers, outside vendors, and other staff to administer treatment and study protocols. May coordinate multi-site studies . + Conduct study ... and sensitive information (written and verbal). + Ability to implement good clinical practices in all interactions with study participants, their families,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strategic and operational process improvements and/or implementation of processes for Clinical Operations. The Sr. Manager , Business Strategy & Operations ... Join Gilead and help create possible, together. **Job Description** The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions… more
- AbbVie (South San Francisco, CA)
- …Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (ie, ... interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other… 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