- Stanford University (Stanford, CA)
- Clinical Trials Regulatory and Quality Specialist **School of Medicine, Stanford, California, United States** **New** Research Post Date 4 days 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
- Gilead Sciences, Inc. (Foster City, CA)
- …to develop clinical supply strategies and plan with the focus on delivering compliant, quality IMP to clinical trials globally on time in full. + Ensures ... . Works collaboratively within the department and with cross functional colleagues (eg, Regulatory , Clinical Operations, Quality , PDM sub-teams, GSC, etc.)… 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 (San Mateo, 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
- 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
- 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
- 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
- BeiGene (San Mateo, CA)
- …scientific knowledge within the Clinical Operations' function to drive faster, high quality clinical trials + Provide expert knowledge on the execution ... the Job:** + Ensures timely planning and delivery of clinical trials with high quality ...implemented consistently across trials + Contributes to Clinical Operations and clinical trial … more
- Gilead Sciences, Inc. (Foster City, CA)
- …SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that supports global registration and commercialization of ... the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas....+ Extensive experience in the delivery of registration-intent oncology clinical trial programs including understanding of oncology… more
- ThermoFisher Scientific (San Jose, CA)
- …research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will ... a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of… more
- BeiGene (San Mateo, CA)
- …team + Strong ability to collaborate and build strategic relationships with internal ( Clinical Operations, Quality , CMC, Regulatory , etc.) stakeholders. + ... Demonstrates advanced knowledge of global clinical trials and the drug development process....functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP, GCP, 21 CFR Part… more
- Gilead Sciences, Inc. (Foster City, CA)
- …therapeutic area, you will lead or support multiple components of clinical trial programs, including primary biliary cholangitis (PBC) and/or ... meet team goals. **EXAMPLE RESPONSIBILITIES:** + Lead or support clinical trial protocol design, clinical ...health authority inquiries + Serve as medical monitor for clinical trials or oversee medical monitoring, including… more
- Stanford University (Stanford, CA)
- …direct patient care setting, electronic medical records. + Knowledge of GCP and clinical trial regulatory process. **EDUCATION & EXPERIENCE (REQUIRED):** ... with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral...research in the South Bay with a focus on quality . We are seeking candidates with excellent organizational skills,… more
- Stanford University (Stanford, CA)
- … Research Manager 2** _Hybrid Work Arrangement_ The Stanford Cancer Institute's Clinical Trials Office (SCI-CTO) is the centralized organization for cancer ... the development, activation, and completion of scientifically impactful cancer clinical trials serving the SCI's catchment area....supporting CRG goals, including strategies to support growth and clinical trial accruals. + Manage and track… more
- Stanford Health Care (Palo Alto, CA)
- … clinical trials , including documentation of criteria specified in the clinical trial . + Uses independent judgement to assess, identify, and prioritize ... Nurse Professional is Central to the Patient Experience on Clinical Trials : o Ensure a good experience...trial . + Other + Follows all institutional and regulatory guidelines, policies and procedures when providing care. Ensures… more
- Stanford University (Stanford, CA)
- …for staff handling research administration activities associated with the conducting of clinical trials . Monitor staffing levels and identify adequate coverage ... strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials . Develop consent forms for approval by Human… more
- System One (Pleasanton, CA)
- …in scientific studies and activities supporting registrational and non-registrational clinical trials . Organizes, conducts and monitors experiments utilizing ... or industry setting. Knowledge, Skills, and Abilities: . Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability… more