- BeOne Medicines (San Mateo, CA)
- …study/project teams supporting hematology studies and interact with Clinical , Regulatory, Statistical Programming, Data Management and other Research ... and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission...to ensure that the data evaluated are in high quality and satisfy analysis requirements. + Collaborates with the… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** This position will be responsible for the management of clinical outsourcing needs in support of BeOne's current and planned clinical ... metrics, and vendor oversight/governance. This position will also be responsible for clinical study budget estimation and budget management during the study life… more
- Pfizer (South San Francisco, CA)
- **ROLE SUMMARY** As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations ... as a harmonized unit with consistent, timely and high quality application of process and delivery of CDS responsibilities....of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all CDIS… more
- GRAIL (Menlo Park, CA)
- …+ **Experience** + Minimum of 10 years of experience in regulatory, development, clinical affairs, quality , or program management within the IVD, medical device, ... 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
- BeOne Medicines (San Mateo, CA)
- **General Description:** + Provide project/program management support on clinical development project teams. + Develop, validate and maintain project schedules ... + Champion and support process improvement initiatives and optimize efficiency, quality and performance. + Collaborate with teams to deliver on commitments… more
- AbbVie (Irvine, CA)
- …core team meetings involving Tissue Management Science, Product Development, Clinical , Medical Affairs, Quality , Regulatory, Health Economics Outcomes ... prioritization of multiple product features and attributes. + Understands and supports clinical studies to optimize promotional and economic claims. + Develops close… more
- Sumitomo Pharma (Sacramento, CA)
- …or follow us on LinkedIn. **Job Duties and Responsibilities** + Lead on clinical studies and manage/provide training to team members when needed. + Contribute and ... Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. + Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate + undefined + Help… more
- BeOne Medicines (San Mateo, CA)
- …evaluations. + Develop and enforce data governance standards, including data quality , security, and compliance through automation. + **Innovation & Rapid ... + Experience working with Life Sciences data, including exposure to R&D, Clinical Operations, TechOps, or Manufacturing domains. Understanding of key systems (CTMS,… more
- BeOne Medicines (San Mateo, CA)
- …CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-approval applications. + Develop ... lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. + Provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The QC Microbiology Director is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides ... operations. Responsibilities include leading the microbiology QC team supporting both clinical and commercial programs for biologics and small molecule sectors. This… more