- Bausch + Lomb (Sacramento, CA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...purposes. **POSITION REQUIREMENTS** **:** + Strong knowledge of Good Clinical Practices ( GCP ), clinical trials… more
- Terumo Neuro (Aliso Viejo, CA)
- …and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices ... **12521BR** **Title:** Sr. Manager, Clinical Data Management **Job Description:** The Senior...Job duties: + Develop and implement SOPs to ensure GCP /ICH compliance for data management, database operations, clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy and associated capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the ... + Analyze new regulations and polices with emphasis Good Clinical Practices ( GCP ) and partner with business...across functions + Significant experience advising business function and senior leadership team on quality & compliance… more
- BeOne Medicines (Emeryville, CA)
- …needs of the business and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and expertise to ... and GDP compliance matters. This role reports to the Senior Director, Global Clinical Operations Compliance Lead....directly related area. + Minimum of 3+ years in GCP -related discipline/ quality assurance role. + Has impeccable… more
- BeOne Medicines (Emeryville, CA)
- …and reconcile all payment information. + Interfaces with cross-functional colleagues in Regulatory, Quality , and Clinical Supply Chain. + colleagues as needed to ... We currently have an exciting opportunity available for an experienced Senior Director, Investigator-Initiated Trials (IIT) and Expanded Access Programs in Global… more
- Cedars-Sinai (Los Angeles, CA)
- …and local Institutional Review Board. + Maintains research practices using Good Clinical Practice ( GCP ) guidelines. + Maintains strict patient confidentiality ... Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency. + Identify quality and performance improvement… more
- Pfizer (South San Francisco, CA)
- …leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and ... all FIH programs through proof-of concept + Set the clinical data review strategy, ensure quality data...Development especially in Early Development + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Clinical Research Monitor Sr. serves as a senior -level ... Research Office (CRO), providing expert oversight and strategic insight into the quality and compliance of clinical research activities at CHLA. This role… more
- Abbott (Alameda, CA)
- …limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. **This role is located ... trials. + Proactively and effectively communicate the status of clinical studies to management. + Ensures quality ...be flexible when priorities change. + Working knowledge of GCP , Clinical and Regulatory Affairs. + Proficient… more
- J&J Family of Companies (Irvine, CA)
- …business units and external customers. + Provide statistical reports for data quality /performance metrics. + Assist Clinical Research with literature reviews and ... (Will consider remote work will be considered) **OVERALL RESPONSIBILITIES:** The Senior Biostatistician will be responsible for designing statistical analysis plans… more
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