- Insmed Incorporated (San Diego, CA)
- …review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor ... clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials , through to full… more
- Insmed Incorporated (San Diego, CA)
- … clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well as ... Research Scientist (CRS) will support and work predominately with the Clinical Trial /Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or… more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory and Quality Specialist **School of Medicine, Stanford, California, United States** **New** Research Post Date 8 hours ago ... Fixed Term 12 months Stanford University is seeking aClinical Trials Regulatory and Quality Specialist... clinical trials operations, knowledge of clinical trials regulatory requirements, or… more
- BeiGene (San Mateo, CA)
- …Builds strong relationships with BeiGene functional leadership (including but not limited to clinical Operation, Quality , Regulatory , CMC, and GRDS) to ... team + Strong ability to collaborate and build strategic relationships with internal ( Clinical Operations, Quality , CMC, Regulatory , etc.) stakeholders. +… more
- BeiGene (Emeryville, CA)
- …strategies, programs, and external engagement + Understanding of the prescription drug regulatory environment and clinical trial submission process in ... Reporting to the Head of Americas, Clinical Operations, the Director - Clinical Trial Diversity, will lead BeiGene's goals to increase global clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance… more
- Stanford University (Stanford, CA)
- Clinical Trial Contracts Officer 1 **School...projects within the School of Medicine. Within RMG, the Clinical Trials (CT) Team focuses on assisting ... drug, device, or treatment to patients. RMG seeks a Clinical Trial Contracts Officer 1 (CTCO) to...The CTCO will serve as a member of the Clinical Trials in the Research Management Group… more
- Hologic (San Diego, CA)
- Clinical Trial Lead San Diego, CA, United...executes clinical operations for simple to complex clinical trials . * Manages project-specific work of ... make a lasting impact on patient lives. As a Clinical Trial Lead (CTL), you'll lead the...budget negotiations and contract execution (as needed to support clinical finance), regulatory document collection, and IRB… more
- Takeda Pharmaceuticals (Sacramento, CA)
- …Manager, Process Excellence and Delivery supports the strategy to develop and maintain quality Global Integrated Clinical Trial Data Services (GICTDS) ... Engineering, Clinical Data Standards, Clinical Trial Tools and Technologies, Risk Based Quality ...and/or regulatory submission experience. + Understanding of clinical trial documents (protocols, statistical analysis plans,… more
- e CancerCare (Fresno, CA)
- Purpose: The Director, Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of ... for contributing to the creation and execution of the clinical trial development strategy, study contract review,...as applicable Works to ensure enrollment goals of the clinical trials program (per site) are being… more
- Gilead Sciences, Inc. (Foster City, CA)
- …policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance… more
- US Tech Solutions (Foster City, CA)
- …required with the collection, delivery and analysis of **biological specimens** within a clinical trial * Provides **sample management** expertise to the Study ... for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest...in life sciences. * Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA) grade… more
- Bristol Myers Squibb (Brisbane, CA)
- …health and optimize product benefit-risk profiles. The VP works cross-functionally with clinical , regulatory , medical affairs, quality , and commercial teams ... affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies. ....unique perspectives in an inclusive culture, promoting diversity in clinical trials , while our shared values of… more
- University of Southern California (Los Angeles, CA)
- …principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating ... information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external… more
- UCLA Health (Los Angeles, CA)
- …studies ensuring adherence to federal/local/institutional regulatory requirements, good clinical practice, data quality , protocol compliance, protection of ... research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist...research budgeting process to assist with the preparation of clinical trial budgets. + Working knowledge of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …portfolio throughout the entire product lifecycle with input from Research, Clinical Development, Regulatory Affairs, Quality , Pharmaceutical Development ... operations and EU QPPV/Affiliates. Reporting to the SVP of Regulatory , Safety and Quality (RSQ), the VP...all therapeutic areas, including having a perspective on how clinical practice and patient needs are evolving as well… more
- Stryker (Fremont, CA)
- …etc. as appropriate to ensure safe, compliant and successful clinical trial conduct. + Participates in driving quality awareness in every employee, ... of corporate-wide clinical standards for content and quality of clinical trial data...with a deep understanding of governance associated with conducting clinical trials , including but not limited to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …experience. + BA/BS with 10+ years' relevant experience. + Significant medical writing, regulatory , quality , clinical R&D, or related experience in the ... participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. + Demonstrated… more
- Cordis (Irvine, CA)
- …in the site's investigator file and sponsor trial master file + Support clinical trial site setup and activation activities + May contribute to the ... CRFs and edit checks + Drives recruitment and retention strategies to support clinical trial enrollment/retention milestones + Manage assigned sites to ensure… more
- AbbVie (South San Francisco, CA)
- …the pharmaceutical industry, academia, or equivalent is preferred. + Knowledge of clinical trial methodology, regulatory and compliance requirements ... industry, academia, or equivalent is preferred. + Knowledge of clinical trial methodology, regulatory and... methodology, regulatory and compliance requirements governing clinical trials and experience in the design… more
