NewClinical Trial Manager Intuitive Surgical IncClinical Trial ManagerSan Carlos, CAThis role is highly operational and execution-focused, partnering closely with clinical sites, CROs/vendors, and internal cross-functional teams to deliver studies on time, within budget, and with high-quality data, with significant responsibility for site startup, training, equipment logistics, data management, and operational issue resolution. U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Clinical Trials Manager Integrated Resources, IncClinical Trials ManagerFoster City, CaliforniaContractorClinical Trials ManagerIn partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
Sr. Manager Clinical Research Engineering Intuitive Surgical IncSr. Manager Clinical Research EngineeringSunnyvale, CAHire, develop and mentor CREs for the program, Presents findings to key opinion leaders, subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design and development of new platforms, procedures, instruments, and accessories. Manager Clinical Research Engineering uses their in-depth clinical, scientific, and technical knowledge to lead, collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts being incubated in early exploration.
Senior Clinical Research Associate Protagonist Therapeutics IncSenior Clinical Research AssociateNewark, CA$135,000–$150,000 / yearSupport study vendor management by performing key activities as delegated by study CTM, including but not limited to: Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors • Manage the day to day interactions with select study vendor(s), such as a central or specialty lab including developing training materials, lab manuals and acting as first point of contact for issue and query escalation and resolution. Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to: Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •.
On-site Clinical Research Associate Protagonist Therapeutics IncOn-site Clinical Research AssociateNewark, CA$125,000–$135,000 / yearThe Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.
Manager, Clinical Lab Management Nektar TherapeuticsManager, Clinical Lab ManagementCA$150,000–$185,000 / yearNektar currently anticipates the base salary for the Manager, Clinical Data Management to range from $150,000 to $185,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience. This role ensures the timely delivery of high-quality biological samples used to evaluate drug efficacy and is an integral member of the study team across study start-up, conduct, and close-out.
Sr. Clinical Study Manager Intuitive Surgical IncSr. Clinical Study ManagerSunnyvale, CAAccountable for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful progress. The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications.
Senior Clinical Program Manager Revolution Medicines, Inc.Senior Clinical Program ManagerRedwood City, CA$164,000–$205,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
Clinical Research Coordinator 2 Apidel TechnologiesClinical Research Coordinator 2Stanford, CAContractorFormally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
Clinical Reseach Coordinator UCSF Medical CenterClinical Reseach CoordinatorSan Francisco, CAIncumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Manager and/or PI with oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
Senior Scientist, Clinical Research Merck & Co IncSenior Scientist, Clinical ResearchSouth San Francisco, CA$117,000–$184,200 / yearCo-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
Clinical Research Coordinator 2 - Head and Neck Oncology CRG (Hybrid) Stanford UniversityClinical Research Coordinator 2 - Head and Neck Oncology CRG (Hybrid)Stanford, CAReporting to the Head and Neck Clinical Research Manager, the CRC2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to provide high quality clinical trial opportunities to patients with endocrine and head and neck related cancer. The Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting.
Sr Mgr, Project Management- AI Clinical Research Kaiser PermanenteSr Mgr, Project Management- AI Clinical ResearchPleasanton, CAManages designated units or teams by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed; partners with key stakeholders and business leaders to ensure products and / or services meet requirements and expectations while aligning with departmental strategies. Manages the alignment, buy-in, engagement and support of diverse project stakeholders by building and maintaining relationships as well as communicating appropriately with internal customers, third party vendors, senior and/or executive management, and business leaders; and clarifying accountability and authority across stakeholders.
Clinical Trials Manager (Biotechnology, Oncology) Exelixis IncClinical Trials Manager (Biotechnology, Oncology)Alameda, CA$136,000–$192,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or, MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or, PhD/PharmD in biological sciences or related field and zero or more years of related experience; or, Equivalent combination of education and experience. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).
Project Manager Clinical Affairs eTeam Inc.Project Manager Clinical AffairsSunnyvale, CARemote$87–$88 / hourAs a key cross-functional partner, this role will collaborate closely with Regulatory Affairs, Quality Compliance, Program Management, Clinical Affairs, Post-Market Surveillance, Regulatory Compliance, Training, Legal, and other stakeholders to strengthen inspection readiness, support compliance execution, and enable achievement of business and clinical quality objectives. Partner with internal stakeholders to develop internal processes, KPIs and drive identified initiatives, Support the development and execution of a proactive, risk-based clinical quality and compliance program that safeguards participant safety, supports data integrity, and promotes continuous improvement across all clinical studies.
Senior Clinical Research Associate Epic-BioSenior Clinical Research AssociateSouth San Francisco, CA$115,000–$121,000 / yearSupport clinical trial manager with site management, including: site startup activities, co-monitoring visits alongside CRO, reviewing monitoring visit reports, coordinating vendor trainings, reviewing study newsletters, and other duties as needed, in alignment with study priorities and CTM guidance. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.
Senior Manager Clinical Affairs Intuitive Surgical IncSenior Manager Clinical AffairsSunnyvale, CAThis role will oversee and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a key cross-functional constituent, this employee will work closely with functions across the organization - Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives.
Clinical Research Associate II Imperative CareClinical Research Associate IICampbell, CA$101,000–$106,000 / yearThe Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Provide in-house clinical operations support by assisting with study documentation, site coordination, and day-to-day clinical trial activities to help ensure successful study execution.
NewSr. Manager, Clinical Operations 10X Genomics IncSr. Manager, Clinical OperationsPleasanton, CA$173,100–$234,100 / yearKey responsibilities for this role include: managing a portfolio of academic collaborations and strategic partnerships according to established milestones and outcomes, leading the operational execution for large-scale, multi-year collaborations with premier academic institutions to generate evidence for future clinical applications of single-cell and spatial technologies, and driving collaboration between internal cross-functional teams and external partners to achieve desired results. Manager, Clinical Operations reporting to the Director, Business Development and Strategic Partnerships will drive the operational execution and strategic management of high-impact alliances central to 10x Genomics' effort to advance future diagnostic applications for single cell and spatial technologies.
Senior Clinical Research Coordinator Cardiology UCSF Medical CenterSenior Clinical Research Coordinator CardiologySan Francisco, CAReporting to Clinical Research Supervisor, the incumbent may have central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.