[Remote] Sr. Clinical Study Manager

Note: The job is a remote job and is open to candidates in USA. Intuitive is a pioneer in robotic-assisted surgery, dedicated to advancing minimally invasive care. They are seeking a Sr. Clinical Study Manager to develop and execute strategies for clinical and outcomes research studies, ensuring regulatory approvals and managing clinical protocols with minimal supervision.ResponsibilitiesAccountable 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 visitsConduct 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)SkillsPrevious 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 mindsetMinimum 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 trainingAccustomed to working in a hospital environment, experience working with nurses and surgeons preferredKnowledge of statistics, statistical methods, and design of experiment is highly preferredBenefitsWe provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.Employees will come onsite when requested by the leader.Shift: DayWorkplace Type: Remote - This job will be remote and/or the job is designed to be performed outside of the office.Company OverviewIntuitive designs and manufactures robotic-assisted surgical systems. It was founded in 1995, and is headquartered in Sunnyvale, California, USA, with a workforce of 10001+ employees. Its website is https://www.intuitive.com/.Company H1B SponsorshipIntuitive has a track record of offering H1B sponsorships, with 38 in 2026, 337 in 2025, 238 in 2024, 181 in 2023, 285 in 2022, 145 in 2021, 138 in 2020. Please note that this does not guarantee sponsorship for this specific role.