Senior Clinical Study Manager

Overview Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. Our technologies, including the da Vinci surgical system and Ion, have transformed how care is delivered for millions of patients worldwide. We are a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here. Primary Function of the Position This position requires a candidate with extensive experience with planning, study start-up, and execution of clinical studies. This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to support regulatory approvals and key evidence initiatives. As a member of the Clinical Affairs team, this role will design and develop clinical protocols and other study documents, interact with key opinion leaders (KOLs), and execute clinical studies (pre-market or post-market) independently or with minimal supervision. This role may mentor other clinical study managers. The candidate will work with clinical research associates (CRAs), clinical trial assistants (CTAs), data management, and biostatisticians to review results, develop clinical study reports, and contribute to clinical publications. During trial execution, the CSM will oversee site selection, site start-up, enrollment, and follow-up, and provide guidance on monitoring needs. The CSM will lead external communication with investigators and study teams. Experience with premarket studies in the United States and/or multi-national studies is preferred, as is experience identifying, reviewing, interpreting, and summarizing clinical literature. Essential Job Duties Accountable for leading assigned clinical research activities Partner with internal stakeholders, investigators, and KOLs to develop study design and concepts, prepare protocol and study outlines, and drive identified initiatives Plan and execute clinical studies including site selection, recruitment projections, and creation of study documents (protocols, case report forms, informed consents, study reports); organize IRB/EC submissions Conduct clinical studies on schedule and within budget while ensuring quality and compliance Oversee external vendors/CROs as applicable Perform on-site and remote site qualification visits, initiations, monitoring, and close-out visits Monitor clinical study data for regulatory and protocol compliance and accuracy Complete source data verification in EDC systems or case report forms to ensure regulatory compliance and data accuracy Liaise with sites and support internal audits/inspections and sponsor audit readiness Negotiate contracts and budgets with external sites in partnership with legal and management Track study progress and provide regular status reports Collaborate with Biostatisticians on data analysis and synthesis to develop study reports and publications Manage site payments and support financial tracking with appropriate tools Organize and drive study meetings and activities Mentor junior clinical study managers; guide CRAs and CTAs on monitoring and study needs Follow corporate SOPs and regulatory requirements (GCP, US and OUS) and proactively manage studies Conduct literature searches to stay informed of relevant knowledge and identify evidence gaps Critically appraise literature and write summaries to inform clinical strategy and protocols Review and revise Clinical Operations SOPs to support continuous process improvement For post-market research, collaborate with commercial groups to understand market trends and align activities with business goals Drive cross-functional alignment with Medical Officers, Medical Affairs, Regulatory, and Market Access Support Health Economics and Outcomes Research with scientific insights for outcomes research development Prepare manuscripts, abstracts, slides, and posters for meetings and publications in partnership with management Support regulatory submission and approval of pre-market studies and respond to regulatory questions on design and results Qualifications Required Skills and Experience Experience managing and implementing pre-market medical device trials; strong knowledge of clinical/outcomes study design Proven experience in protocol and ICF development and regulatory submissions Experience conducting literature searches and appraisal of scientific data Excellent ability to interact with physicians and professionals inside and outside the company Knowledge of GCP, FDA regulations, and related clinical research requirements Experience negotiating clinical research contracts and budgets Ability to work effectively on cross-functional teams Willingness to travel 25-40% or as required Ability to manage multiple projects and priorities Strong communication, presentation, and organizational skills with attention to detail Self-starter with ability to adapt to shifting requirements and learn about surgical specialties as needed Ability to lead teams of CRAs and CTAs and provide study updates Demonstrates a solid work ethic and problem-solving mindset to meet timelines Required Education And Training Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D., or M.D.) with at least 5 years in industry-sponsored clinical research; or a Bachelor's with at least 8 years in industry-sponsored clinical research; or 10 years of relevant experience Preferred Skills And Experience Experience in a hospital environment; working with nurses and physicians is preferred Knowledge of statistics and design of experiments is highly preferred Additional Information Due to the nature of our business, vaccination requirements may apply. 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. Mandatory Notices U.S. Export Controls: Some roles may be subject to U.S. export controls. Final offers may be contingent upon obtaining an export license or an executed Technology Control Plan. We will consider qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference may be given to candidates not residing in certain locations. This position may be filled at a different job level based on business need and candidate experience. Compensation will be based on the level and qualifications. Base salary ranges: Region 1: $151,700 - $218,300; Region 2: $128,900 - $185,600. Shift: Day. Workplace Type: Set Schedule; onsite presence as defined by leadership. #J-18808-Ljbffr Intuitive