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.
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.
Principal Scientist, Clinical Research - Immunology/Dermatology Merck & Co IncPrincipal Scientist, Clinical Research - Immunology/DermatologySouth San Francisco, CA$255,800–$402,700 / yearAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
Senior Director, Clinical and Translational Research Omada Health IncSenior Director, Clinical and Translational ResearchCA$243,800–$304,800 / yearLead the development and interpretation of health economics and outcomes research (HEOR), including cost-effectiveness, budget impact, and total cost of care analyses that clearly articulate value to Medicare Advantage plans, commercial employers, and provider partners. Deep expertise in health economics and outcomes research (HEOR), including hands-on and/or leadership experience with healthcare claims analysis, cost and utilization modeling, and total cost of care analyses for Medicare Advantage and commercial employer populations.
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 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.
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 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) •.
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.
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.
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.
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).
Clinical Care Manager I Felton InstituteClinical Care Manager ISan Mateo, California$43–$48 / hourFull timeFunded through partnerships with county behavioral health departments, the Felton Early Psychosis Division operates outpatient coordinated specialty care for early psychosis programs in San Francisco, Alameda, San Mateo, and Marin, and offers excellent training and workforce development. This includes evaluating the strengths and needs of participants; identifying treatment goals collaboratively with participants and team members; and providing therapeutic interventions that target psychosis, mood, and additional issues that may impact recovery (such as trauma, substance use, interpersonal problems, and environmental stressors, etc.).
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.
Clinical Study Operations Engineering Program Manager - Health Apple IncClinical Study Operations Engineering Program Manager - HealthSunnyvale, CABy tailoring communication and leading through influence, align cross-functional teams across engineering, clinical, legal, and business development to resolve unpredictable operational challenges B.S. degree in biomedical engineering or any engineering discipline, or equivalent 10+ years of direct experience in clinical project management, strategic partnerships, or clinical operations within Health or Technology Strong human research background with a comprehensive understanding of the end-to-end study lifecycle, GCP, and domestic/international regulations Proven track record of managing and onboarding global CROs and diverse external vendors Ability to knit together disparate sources of information into a strong strategic narrative and perform data analysis to drive measurable results Expert analytical and negotiation skills, adept at facilitating actions, resolving conflicts, and delivering crisp, effective communication to executive leadership Proven ability to project manage and oversee clinical data management activities, ensuring adequate resourcing, vendor compliance, and strict data integrity across the study lifecycle. Self starter and critical thinker with the ability to work autonomously, establish priorities, and thrive in a highly ambiguous, fast paced environment Superb communication skills including effective listening, clear and concise writing, and the ability to articulate complex project updates to executives Ability to be onsite; this role is a hybrid, in-person position Some travel is required, approximately 25%.Experience leveraging AI, digital platforms, or advanced analytics in clinical recruitment and study operations Direct experience strategizing and mapping clinical operations for OUS regions.
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 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.
Regional Clinical Operations Manager JumpstartMDRegional Clinical Operations ManagerBurlingame, CaliforniaWe are seeking an individual with a proven track record in multi-site operations leadership, a deep commitment to exceptional member experience, and the leadership instincts to develop and inspire Clinician Managers across our Bay Area region. Are you an experienced operations leader with a passion for healthcare and wellness — someone who thrives in a fast-paced, multi-site environment and knows how to develop great managers, drive results through data, and create a culture of accountability and excellence?
Manager, Clinical Supply Chain Mirum PharmaceuticalsManager, Clinical Supply ChainFoster City, California$130,000–$140,000 / yearReporting to the Executive Director, Clinical Supply Chain, the Manager is responsible for the global supply and distribution of investigational drug productfor Mirum’s ongoing clinical trials inclusive of the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. Supports the preparation and review of Mirum documentation including regulatory applications, clinical trial applications, routine amendments, protocols, briefing documents, Quality Technical Agreements, responses to health authority inquiries, and other documents as required.