- Pfizer (South San Francisco, CA)
- …key study team members such as the Clinician, Clinical Operations + Study Team Lead and Compliance Oversight Lead , as well as Business ... TMF Operations' activities to enable complete, compliant and consistent study TMFs for interventional studies across the...Drive performance of CRO against TMF requirements, including TMF Study Ownership and Clinical + Document Management… more
- BeiGene (San Mateo, CA)
- …the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with ... progress in the region to senior management and Global Clinical Study Manager as required + Represents...in clinical research including relevant experience as team lead in clinical functions… more
- Meta (Burlingame, CA)
- …passionate, and able to execute consistently in a fast-paced environment. **Required Skills:** Clinical Study Lead , Health and Wellbeing Responsibilities: 1. ... Wellbeing team is seeking a highly experienced clinical study manager to support clinical...projects, regulatory studies , and a variety of clinical study designs and modes of … more
- BeiGene (San Mateo, CA)
- …financial goals + Works with the sourcing team to strategize regional study vendor needs. + Works closely with Clinical Business Operation on optimizing ... provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers at various levels for...agreed timelines and budget + May act as regional lead (if needed) for one or multiple studies… more
- BeiGene (San Mateo, CA)
- …study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads or co- lead aspects of a ... The Associate Director (AD) Clinical Study Management leads both indirect...management to COM or CTA CTA staff to ensure clinical studies at a project level are… more
- BeiGene (San Mateo, CA)
- …NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members + Lead the authoring of Storyboards ... clinical discussions + Apply effective communication skills to lead and facilitate safety team meetings and...Plans, CSRs (incl. China ADR Summary) and other relevant project/ study documents and answer ad-hoc safety queries from ethics… more
- Stanford University (Stanford, CA)
- …+ Develop project schedules, keep targets, measurements, and accountabilities, as assigned. Lead team and clinic operations meetings and prepare/approve minutes. ... Cancer Clinical Research Supervising Lead - Cancer...Demonstrated project/program leadership skills. + Demonstrated disease knowledge / study design experience of studies under purview.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …complex assignments that enable multiple functions and teams to achieve their clinical study objectives within targeted timelines and allocated resource levels. ... and optimize performance across study teams (systems and technology, study design, decentralization, team /stakeholder communication, etc) + Partner with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …independence, you will typically lead clinical pharmacology strategy and clinical pharmacology studies in Oncology with a focus on combinations involving ... reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study ...responsibilities for leading the respective cross-functional study team . + With input from others, designs clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in Foster City, CA_ **POSITION OVERVIEW:** With increasing independence, you will typically lead clinical pharmacology studies of moderate complexity in ... reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study ...responsibilities for leading the respective cross-functional study team . + With input from others, designs clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members.... studies . + Proven ability to effectively author clinical study documentation. + Functional expertise to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... of clinical studies . + Proven ability to effectively author clinical study and regulatory documentation. + Ability to lead and influence programs,… more
- Stanford University (Stanford, CA)
- …+ Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. + Formally supervise, ... a Clinical Research Coordinator 2 to conduct clinical research studies in depression, anxiety, and...independently manage significant and key aspects of a large study or all aspects of one or more research… more
- Stanford University (Stanford, CA)
- …will be working with a team of study coordinators to lead a multicenter clinical trial investigating the mechanisms of peripheral nerve stimulation. Work ... years) to perform duties related to the coordination of clinical studies . Qualified candidates will coordinate moderately...the principal investigator and/or study coordinator/supervisor. The CRCA… more
- Stanford University (Stanford, CA)
- …will be responsible for day-to-day operations of two or more clinical studies , working with a highly collaborative team that includes Principal and ... Clinical Research Coordinator 2 (Fixed-term 2 years) **School...Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. +… more
- Stanford University (Stanford, CA)
- …+ Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. + Formally supervise, ... Clinical Research Coordinator 2 **School of Medicine, Stanford,...studies to develop recruitment and retention strategies, oversee study operation and conduct, oversee regulatory compliance and financial… more
- Stanford University (Stanford, CA)
- …internal clinical studies and present monitoring forms to the quarterly clinical operations meetings. + Lead the study -specific weekly meeting. + ... + Ability to organize work and multi-task. + Experience with maintenance of clinical study binders and interface with electronic record-keeping methodologies (or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …R&D Quality is seeking a Senior Director, Inflammation TA Lead to join our Clinical Quality Business Partners Leadership Team . In this role you will lead ... drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and...implement the Quality Strategy for the Inflammation TA. + Lead and direct assessment of Inflammation risk areas and… more
- AbbVie (South San Francisco, CA)
- …(ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (ie, Clinical ... and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses,...out the best in others on a cross-functional global team . Must be able to lead and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and studies . The Director will have experience in global clinical development and operations, innovative thinking, program/ study design and execution, ... as a Design & Innovation leader and trusted business partner with program and study team leadership, collaborating toward the successful design and execution of… more