- BeOne Medicines (San Mateo, CA)
- …(eg, Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance.) + Experience ... **General Description:** The Associate Director (AD), GCOE Learning and Development responsible for...the Learning Management System (SumTotal or equivalent) for Global Clinical Operations (GCO). This role ensures the delivery and… more
- AbbVie (San Francisco, CA)
- …succeed + Responsible for executing clinical programs in compliance with quality standards (ICH/ GCP , Global Regulations, and AbbVie policies and procedures) ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Clinical Operations Program Director is responsible to connect science… more
- Gilead Sciences, Inc. (Foster City, CA)
- …SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of ... Gilead's products. **Key Responsibilities:** + In partnership with Clinical Program Manager or Associate Director , provides...Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice ( GCP ) and key Clinical… more
- GRAIL (Menlo Park, CA)
- …the Data Transfer Plan with External Data Providers or collaborators. + Assist Director of Clinical Data Management and other GRAIL staff with developing ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome… more
- Providence (Orange, CA)
- …Nursing experience in Research or Oncology Nursing. **Preferred qualifications:** + Coursework/Training: GCP training. + 1 year of Oncology Clinical Trials ... direction of the Cancer Research Manager, the Cancer Center Medical Director and other participating physicians conducts all protocol specific research activities… more
- Pfizer (South San Francisco, CA)
- **POSITION SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for ... program. + Responsible for scientific oversight, data integrity and quality of the clinical trial(s). + Represent...of the sponsor leading studies + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity… more
- Ascendis Pharma (Palo Alto, CA)
- …all safety reports received from any source are reviewed according to ICH- GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with ... Medical Monitors in Clinical Development to ensure that appropriate medical review and...of products in development. . Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation… more
- Ascendis Pharma (Palo Alto, CA)
- …are processed in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business ... the oversight of the PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.… more
- Ascendis Pharma (Palo Alto, CA)
- …are processed in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business ... the oversight of the PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.… more