Sr. Clinical Study Manager

Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.Job DescriptionPrimary Function of the PositionThis position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be accountable 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 help 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 premarket studies in the United States 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 DutiesAccountable for leading assigned clinical research activitiesPartner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiativesAccountable 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 progressAccountable for autonomously 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 help in internal audit/inspection and ensure sponsor audit readinessLiaise with external vendors and sites to negotiate contracts and budgets in partnership 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 help development of scientific publicationsTrack, process and manage site payments and help in study financial tracking by developing tracking tools as necessaryOrganize and drive 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 establish 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, partner with commercial groups (i.e., marketing) to know about market trends and utilize information to help 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 review (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 partnership with managementHelp regulatory submission and approval of pre-market clinical studies and 510k(s), accountable 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, helping and managing medical device trials Significant knowledge of clinical and/or outcomes research study designProven experience in protocol and ICF development, writing clinical section(s) for regulatory submissionProven 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 knowledge 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 based on business requirementsMust be able to manage multiple projects and/or manage different prioritiesProven communication, presentation and relational skills with high attention to detail and organizationAbility to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updatesExhibits solid work ethic to help meet tight 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 training.Preferred Skills and ExperienceAccustomed to working in a hospital environment, experience working with nurses and surgeons preferredKnowledge of statistics, statistical methods, and design of experiment is highly preferredAdditional 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). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.SummaryType: Full-timeFunction: Public RelationsExperience level: AssociateIndustry: Medical Device