Senior Clinical Study Manager (Sunnyvale)

Company DescriptionIt started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.Job DescriptionPrimary Function of the PositionThis position requires a candidate with extensive experience supporting evidence generation strategy and execution of clinical studies. The Senior (Clinical Study Manager 4) role will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision. 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 support the development of clinical publications. During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. The CSM will also take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience previously managing multi-center, premarket studies in the United States (IDE for 510k or PMA submissions) and utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature.Essential Job DutiesResponsible for leading assigned clinical research activitiesCollaborate with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiativesResponsible for the planning and execution of the clinical studies including site selection, analysis 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 progressResponsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliancePerform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits.Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring planComplete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites or in data listings to ensure regulatory and protocol compliance and overall accuracyLiaise with sites and support in internal audit/inspection and ensure sponsor audit readinessLiaise with external vendors and sites to negotiate contracts and budgets in collaboration with the legal team and managementTrack study progress and provide regular status reportsWork closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or support development of scientific publicationsTrack, process and manage site payments and support in study financial tracking by developing tracking tools as necessaryOrganize and lead study meetings and other study activities as assignedMentor junior clinical study manager(s); provide guidance to CRAs and CTAs on monitoring and other study needsFollow corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines) and proactively manage studies, following such guidelines and requirementsConduct literature searches and familiarize with literature to stay informed and abreast of relevant scientific/clinical knowledge and/or to determine evidence gapsCritically appraise scientific literature and write clinical summaries to assist research and the development of clinical strategies and clinical investigational protocolsReview and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs leadership with continuous process improvement initiativesFor post-market research, collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activitiesFor post-market research, provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest)Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications in collaboration with managementSupport regulatory submission and approval of pre-market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports).QualificationsRequired Skills and ExperiencePrevious experience implementing, supporting and managing medical device trials Significant knowledge of clinical and/or outcomes research study designStrong experience in protocol and ICF development, writing clinical section(s) for regulatory submissionStrong experience in conducting literature searches, reviews and appraisal of the scientific dataExcellent ability to interact with physicians and other professionals inside and outside the companyKnowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental understanding of clinical research and monitoring requirementsExperience negotiating clinical research contracts and budgetsMust be able to work effectively on cross-functional teamsMust be able to travel 25-40% or depending on business requirementsMust be able to manage multiple projects and/or balance competing prioritiesStrong communication, presentation and interpersonal skills with high attention to detail and organizationAbility to learn quickly, adapt to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)Ability to lead project team consisting of CRAs and CTAs and support management with relevant study updatesExhibits strong work ethic to help meet aggressive timelines or multiple projects when necessary with a problem-solving mindsetRequired Education and TrainingMinimum Advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant trainingPreferred Skills and Experience Comfortable in a hospital environment, experience working with nurses and surgeons preferredUnderstanding of statistics, statistical methods, and design of experiment is strongly preferredExtensive experience with close and independent management of pre-market clinical studies (First Human Use or IDE) used for regulatory submissionsStrong track record of KOL management for multi-center studiesExperience working on global or multi-national studiesAdditional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.Mandatory NoticesU.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 employeeswho are nationals from countries currently on embargo or sanctions status.Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). 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