- Bristol Myers Squibb (Brisbane, CA)
- …(input on inclusion/exclusion and other safety-related clinical considerations) + Fulfills GCP and compliance obligations for clinical conduct and maintains ... all required training + Acts as a focal point for defining and establishing relationships with key global Phase I Centers + Works on multiple trials across early development clinical lifecycle **Clinical Development Expertise & Strategy** + Designs and… more
- Bristol Myers Squibb (San Diego, CA)
- …(input on inclusion/exclusion and other safety-related clinical considerations) + Fulfills GCP and compliance obligations for clinical conduct and maintains ... all required training Clinical D evelopment E xpertise & S trategy + In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze ... Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions + Collaborate with...new regulations and polices with emphasis Good Clinical Practices ( GCP ) and partner with business experts and stakeholders to… more
- Sumitomo Pharma (Sacramento, CA)
- …protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical ... and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory requirements. **Key Core Competencies** : + A proven,… more
- Cardinal Health (Sacramento, CA)
- …Flux). - Implement security controls (eg, Pod Security Admission, Secrets Management with GCP Secret Manager) and ensure compliance with HIPAA, SOX and other ... Monitor cluster health and application performance using Dynatrace, Prometheus, and GCP Cloud Monitoring/Logging, performing root cause analysis for incidents. -… more
- Lilly (San Diego, CA)
- …as well as regulatory strategy development + Monitor patient safety and ensure compliance with GCP , FDA, ICH guidelines, and company policies **Cross-Functional ... Leadership & Influence** + Serve as scientific and medical expert across multiple therapeutic programs simultaneously + Lead early clinical strategy in cross-functional teams through matrix influence, aligning diverse stakeholders around common objectives +… more
- Gilead Sciences, Inc. (CA)
- …trial teams + Supervise clinical teams and external vendors to maintain document compliance with ICH- GCP and SOPs + Partner with Quality Assurance/ Compliance ... and Functional Service Providers (FSPs) to ensure Trial Master File (TMF) compliance with industry standards and regulations. This role supports inspection readiness… more
- ICON Clinical Research (Los Angeles, CA)
- …visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH- GCP , SOPs, and regulations + Maintain up-to-date ... and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting… more
- KBR (Carlsbad, CA)
- …meshes (eg, Istio) + Experience with hybrid or multi-cloud container deployments (AWS, GCP , Azure) + Knowledge of security compliance standards (eg, SOC2, ISO ... 27001) as applied to container deployments and software applications This is a hybrid remote position in Carlsbad, CA- the selected candidate will be required to work in the office at least 3 days per week. Additional Notes: The selected applicant may be… more
- Astrix Technology (Los Angeles, CA)
- …such as forms, templates, and work instructions. + Ensure adherence to SOPs and compliance with relevant standards, including ICH GCP E6 (R2). + Lead the ... **Clinical Compliance Auditor** Clinical Los Angeles, CA, US Pay...engineering discipline + 4-7 years of experience in a GCP -Biologics or pharmaceutical environment. + CQA or other audit… more