- BeiGene (Emeryville, 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
- BeiGene (Emeryville, 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 (Emeryville, 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
- Pfizer (San Francisco, CA)
- …for mitigation + Leader of the Local Study Team (core members: ( Lead ) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation ... The Study Operations Manager has responsibility for study management aspects of assigned studies of...larger Study Management team . The Study Operations Manager I may lead specific… more
- Bristol Myers Squibb (Brisbane, CA)
- …to design and deliver clinical studies and programs. + Leads the Clinical Science team in the planning and execution of clinical trial activities ... across studies and provide oversight of all clinical studies within assigned area + May...assigned plans; Provide program/ study /therapeutic area/skills training to team members + Represent Clinical Science … 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
- Pfizer (San Francisco, CA)
- …to a team of medical directors and clinical scientists who lead the clinical study team for 1 or more medicines in prostate cancer + Oversee the ... of therapies for multiple medicines in prostate cancer + Lead product specific Global Development Team +... clinical protocols and amendments, investigator brochures, and clinical study reports + Provide oversight and… 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
- Abbott (Alameda, CA)
- …clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/ Study Lead as needed. + Proactively and ... effectively communicate the status of clinical studies to management. + Participate in...skills including building rapport with team members/peers, study site staff, and clinical management. +… 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
- 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
- Vera Therapeutics (Brisbane, CA)
- …Data Management (CDM) department plays an integral role as part of the cross-functional study team . Clinical Data Management is responsible for the ... to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered... studies from study start-up through study closure in support of clinical trial… more
- Bristol Myers Squibb (Brisbane, CA)
- … team of supporting Clinical Scientists (matrix leadership) + Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with ... cross functional study team members + May support clinical development...educate supporting team members + Plan and lead the implementation all study startup/conduct/close-out activities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring ... products + May lead the Global Development Team for assigned molecules; providing scientific and clinical...+ Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical… more
- Bristol Myers Squibb (Brisbane, CA)
- …for a group of studies + Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical ... Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops ... Scientists to allow for protocol-specific training, supporting the study team , investigators, and others Health Authority… more
- Abbott (Pleasanton, CA)
- …and hemodynamic monitoring. This position will work closely within the cross-functional clinical study team including project management, medical affairs, ... to questions from regulatory authorities about existing submissions + Lead publications for clinical study ...a cross-functional team member. + Experience in clinical research studies collaborating with cross-functional … more
- BeiGene (Emeryville, CA)
- …per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard ... responsible for the management and oversight of their assigned clinical study sites to ensure data quality...review and other managerial tasks as needed * Perform study -specific training with project team * Develop… more