- Gilead Sciences, Inc. (Foster City, CA)
- …input on activities including study protocol preparation, other study or investigator documentation, medical monitoring, data analysis plans, study reporting, and ... including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data… more
- BeOne Medicines (Emeryville, CA)
- …concepts, synopses, protocols, and amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and manuscripts ... Update Reports + Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports + Risks / benefits analysis for applicable… more
- IQVIA (Los Angeles, CA)
- …to clinical trial sites and review clinical practice topics as requested by the investigator or referring sites. + Act as the point of contact with thought leaders ... for investigator -initiated study (IST's) ideas within company pipeline assets. +...respective requirements of the customers are met. Reports of drug risks are sent in writing directly to the… more
- Cedars-Sinai (Beverly Hills, CA)
- …trial budgets for industry, National Institutes of Health (NIH), and investigator -initiated clinical research. Evaluates research protocols to assess resource needs, ... procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines cost...all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. **Primary… more
- Sumitomo Pharma (Sacramento, CA)
- …Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health Hazard… more
- Cedars-Sinai (Los Angeles, CA)
- …of the top hospitals in the nation by US News & World Report. **Principal Investigator , Dr. Keith Black, MD, is seeking a Postdoctoral Scientist to join the team!** ... and collaboratively, contributing to the ground breaking research in PDT, PBM, and drug delivery systems. You will be responsible for a range of tasks, from… more
- BeOne Medicines (Emeryville, CA)
- …development, update, and review of safety communication documents (eg, Dear Investigator Letter, Informed Consent Form, Investigator 's Brochure, Healthcare ... review of the Safety Management Plans. + Lead Safety Science specific investigator training. + Risk Assessment, Regulatory Inquiries, and Periodic Reporting. + Lead… more
- Bausch + Lomb (Sacramento, CA)
- …areas to provide input on study-related documents and issues (DMP, SAP, drug /device supplies, CSR, etc.). + Provides clinical operations input in the identification, ... Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug /Device Safety, and Clinical Supplies), and external consultants to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data ... scientific and clinical leadership or oversight in the preparation of investigator brochures + Provide scientific and clinical leadership to cross-functional teams… more
- BeOne Medicines (San Mateo, CA)
- …development, update, and review of safety communication documents (eg, Dear Investigator Letter, Informed Consent Form, Investigator 's Brochure, Healthcare ... review of the Safety Management Plans + Lead Safety Science specific investigator training **Risk Assessment, Regulatory Inquiries, and Periodic Reporting** + Lead… more