- 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)
- …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...Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance… 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
- BeiGene (San Mateo, CA)
- …Global Clinical Operations' productivity, reduce rising costs of clinical trials , and reduce clinical trial inefficiencies + Monitor, evaluate, and ... increase Global Clinical Operations' productivity and reduce clinical trial inefficiencies. This will be achieved...the GCO teams in Planning, Start-up, Managing and Closing clinical trials , and ensuring data are accurate,… 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
- 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
- Stanford University (Stanford, CA)
- …is required. + Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB. + ... + Demonstrated excellent communication skills in speaking and writing. + Multisite clinical trial management experience. + Some project management experience. +… more
- San Jose State University (San Jose, CA)
- …for an advanced career in clinical operations management, clinical trials monitoring, quality , regulatory , and the complex interdisciplinary process ... drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance,… more
- BeiGene (San Mateo, CA)
- …with CRAs to ensure data collection is met per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to ... responsible for the management and oversight of their assigned clinical study sites to ensure data quality ...CTMS and data management systems **Other Qualifications:** * Understands clinical trial processes with a thorough knowledge… more
- Stanford University (Stanford, CA)
- …sharing data through an interlinked network of satellite centers to conduct innovative clinical trials . Our research efforts extend beyond allergies and asthma ... is to achieve the goals of providing the highest quality of clinical services to the patients...allergies, and gastrointestinal diseases. Through laboratory and computational research, clinical trials , and community outreach, we are… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced ... that inspires teams while providing expertise for Gilead's global clinical trials . They work collaboratively with ... supply management as well as changes in the regulatory landscape that would impact clinical supply… more
- BeiGene (San Mateo, CA)
- …and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing ** Quality :** + Handles escalated issues or ... Summary:** + Accountable for regional study delivery with appropriate inspection readiness quality , within agreed timelines and budget + Acts as regional lead for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to deliver future-state capabilities which lead to robust, scalable solutions to support clinical trial activities and that align to IT enterprise strategy and ... drive customer success with Veeva's clinical solutions. + Extensive knowledge in clinical trial operations and processes. + Provide technical support during … more
- Gilead Sciences, Inc. (Foster City, CA)
- …working collaboratively to achieve team goals.** **EXAMPLE RESPONSIBILITIES:** **Lead or oversee clinical trial protocol design, analysis planning, clinical ... regulatory filings; real world evidence strategies to support clinical programs; and efforts to advance value proposition for...or oversight in the preparation, review, and interpretation of clinical study data, ensuring high quality data**… more
- Stanford Health Care (Palo Alto, CA)
- …research nurse manager. To direct clinical course of research participants in clinical trials , oversee study conduct and assure study participant safety. The ... Development Program comprises of Phase 1 and Precision Oncology clinical trials , offering novel therapies to patients...of community resources. + 16. Ensures compliance with legal, regulatory and clinical policies and procedures. +… more
- Stanford University (Stanford, CA)
- …human subject studies relevant to precision medicine in mental health and neuroimaging trials + Experience with FDA regulatory procedures and reporting + ... Clinical Research Coordinator Associate **School of Medicine, Stanford,...Personal." Our ethos is collaborative and one that believes quality science goes hand in hand with mutual respect… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Provide Statistical leadership to Virology clinical trials : developing trial design options and providing high quality decision support. + Statistical ... submissions. If you have a solid background in clinical trial design and analysis and are...technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent… more
- BeiGene (San Mateo, CA)
- …Computer Science or related degree + 10+ years' experience in drug development, managing clinical trial data and analytics + 5+ years in leadership roles as ... & generate reports, descriptive, prescriptive and predictive analytical insights + **Data Quality and Integration** : Oversee Clinical Operations data model,… more