- Stanford Health Care (Palo Alto, CA)
- …Health Care job.** **A Brief Overview** The Clinical Documentation Integrity (CDI) Service Line Outcomes Lead is responsible for partnering with service ... goal setting and problem solving. + Optimizes service line clinical documentation integrity programs, including...project management processes and systems with the ability to lead teams and manage high-profile projects to produce results… more
- BeOne Medicines (San Mateo, CA)
- …readiness and documentation standards for performance tracking systems. + Lead improvement initiatives across clinical functions informed by metric analysis. ... informed by operational data and industry benchmarks, to assess and help improve clinical operations performance. + Lead clinical operations ad-hoc analysis… more
- GRAIL (Menlo Park, CA)
- …and healthcare companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities for one ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- … integrity , inclusion, teamwork, and excellence. Job Description You will typically lead multiple components of clinical trial programs in immunology ... documentation , contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation , publications and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …conduct of clinical studies. + Proven ability to effectively author clinical study documentation . + Functional expertise to initiate, author, or contribute ... their aspirations. Join Gilead and help create possible, together. **Job Description** Clinical Operations is responsible for the worldwide execution of all Phase I… more
- Vera Therapeutics (Brisbane, CA)
- …operating procedures (SOPs) and quality control systems to ensure traceability, documentation integrity , and regulatory alignment, working collaboratively with ... Oversee clinical trial readiness, including compliant labeling, packaging, and documentation for regulatory submissions. * Maintain audit readiness and lead … more
- Stanford University (Stanford, CA)
- …timelines and manufacturing schedules. Mainly focused on CART therapies. + Lead clinical materials manufacturing campaigns; responsible for oversight and ... Lead CCT (Center for Cancer Cell Therapy) human clinical materials biomanufacturing campaigns as an operator or verifier....of and experience generating SOPs, batch records, and other documentation for clinical manufacturing of cell and… more
- BeOne Medicines (San Carlos, CA)
- …Scientist with deep expertise in mass spectrometry-based bioanalysis to join our Clinical Biomarker laboratory. This role will lead the development, validation, ... in complex biological matrices. + Design experimental plans and lead execution of clinical sample analysis to...bioinformatics teams to ensure assay and data alignment with clinical objectives. + Author and review technical documentation… more
- BeOne Medicines (San Mateo, CA)
- …standards and practices. The position will play a critical role in safeguarding the integrity , safety, and quality of clinical research processes and data. This ... within R&D Quality is a senior Auditor role (as Lead or Co-auditor) who is responsible for independently overseeing...and applicable global & local regulations and guidance for clinical development. + Strong global mindset and knowledge about… more
- Bristol Myers Squibb (Brisbane, CA)
- …for global regulatory strategy within a development team (DT). Serve as team lead or co- lead of marketing application submission teams for indications that ... **Position Responsibilities:** + Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common… more
- BeOne Medicines (San Mateo, CA)
- …BeOne's internal audit operations, Regulatory Affairs, Quality, Pharmacovigilance, Safety, Clinical , CMC and other teams to implement sustainable compliance controls ... risk management status reports; develop related training as needed. **Systems, Data Integrity & Workflow Optimization** + Ideate and support the implementation of… more
- Stanford Health Care (Palo Alto, CA)
- …America) **This is a Stanford Blood Center job.** **A Brief Overview** Lead and administer processing laboratory functions under minimal supervision. May be required ... completeness, and accuracy of test results. Conduct performance evaluations of staff. + Lead the planning and operations for functions or programs that may have… more
- AbbVie (South San Francisco, CA)
- …therapies, such as monoclonal antibodies, bi-specifics and novel modalities, to human clinical studies and eventual licensure. This role will be imbedded in a ... cell culture processes for drug substance GMP production to enable human clinical studies and eventual licensure cell culture. As a senior scientist, you… more
- Abbott (Santa Clara, CA)
- …new product development of a novel, non-invasive mitral valve replacement technology and lead completion of design control deliverables. **What You'll Work On** + ... Lead on-time completion of Design Control deliverables + Create...activities + Ensure Device History File (DHF) content completion, integrity , and regulatory & standards compliance; collaboratively identifying, communicating… more
- J&J Family of Companies (Santa Clara, CA)
- …. + Supporting regulatory submissions across geographies and clinical indications. **Qualifications** **Required Knowledge/Skills, Education, And Experience:** + ... IEC 60601 device compliance. In this role, you will lead the effort to test our surgical robotic system...complex capital medical device equipment. + Experience in signal integrity and RF Design. + Experience with python, Linux,… more
- AbbVie (South San Francisco, CA)
- …biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure. AbbVie's Biologics CMC Analytical Research and ... and automation. In this role, you will report to the Process Analytics team lead and be responsible for analytical testing and evaluation of process intermediates to… more
- Bristol Myers Squibb (Brisbane, CA)
- …of full-stack and ML engineers; foster better-than-best practices in code quality, documentation , and UX research. + Partner with discovery leads, IT operations, and ... model evaluation, lineage tracking . + **Influence & communication** - lead architecture reviews, map tech choices to scientific KPIs, mentor cross-functional… more