Sr. Clinical Study Manager

Job Description Position: Clinical Study Manager-4 (CSM IV). This role is part of the Clinical Affairs team and is responsible for developing and executing strategies for clinical and outcomes research studies to support regulatory approvals and key evidence initiatives. Responsibilities Lead assigned clinical research activities. Partner with internal stakeholders, investigators and KOLs to develop and review study design, prepare protocols and study outlines, and drive initiatives. Plan and execute clinical studies, including site selection, patient recruitment projections, and creation of study documents (protocols, case report forms, informed consents, trial agreements, study reports). Ensure studies are conducted on schedule, within budget, and maintain high quality and compliance. Perform site qualification visits, initiation visits, interim monitoring, and close‑out visits. Conduct clinical study monitoring to ensure regulatory and protocol compliance and data accuracy. Complete source data verification in EDC systems or case report forms. Liaise with sites for audits, inspections, and sponsor audit readiness. Negotiate contracts and budgets with external vendors, in partnership with legal and management. Track study progress and provide regular status reports. Work with biostatisticians on data analysis and develop clinical study reports or scientific publications. Manage site payments and develop financial tracking tools as needed. Organize and drive study meetings and other study activities. Mentor junior managers and guide CRAs/CTAs on monitoring needs. Follow corporate SOPs and regulatory requirements (GCP, ICH, US and OUS guidelines). Conduct literature searches, appraise scientific literature, and write clinical summaries. Revise Clinical Operations SOPs to support continuous improvement. Partner with commercial groups for post‑market research insights. Provide scientific expertise to Health Economics and Outcomes Research for outcomes research reviews. Collaborate on manuscripts, abstracts, slide and poster presentations for scientific meetings. Support regulatory submissions and approvals of pre‑market studies and 510(k)s, addressing regulatory queries on design and results. Required Skills and Experience Experience implementing and managing medical device trials and clinical research. Strong knowledge of clinical and/or outcomes research study design. Proven experience in protocol and ICF development for regulatory submissions. Proven experience conducting literature searches and appraising scientific data. Excellent interpersonal skills to interact with physicians and other professionals. Knowledge of GCP, ICH/GCP, and other applicable regulations. Experience negotiating clinical research contracts and budgets. Ability to work effectively on cross‑functional teams. Willingness to travel 25‑40%. Ability to manage multiple projects and prioritize effectively. Strong communication, presentation, and relational skills with attention to detail. Self‑starter attitude, ability to learn quickly, tailor to shifting requirements. Ability to lead a team of CRAs and CTAs and provide relevant study updates. Demonstrated work ethic to meet tight timelines and deliver multiple projects. Required Education and Training Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D., or M.D.) with at least 5 years of clinical research experience; or Bachelor’s degree in a scientific/bioengineering field with at least 8 years of experience; or A minimum of 10 years of clinical research experience with relevant training. Preferred Skills and Experience Experience working in a hospital environment, preferably with nurses and surgeons. Knowledge of statistics, statistical methods, and design of experiments. Benefits We provide market‑competitive compensation packages including base pay, incentives, benefits, and equity. Base salary ranges are: Region 1: $151,700 – $218,300 Region 2: $128,900 – $185,600 Shift: Day; Workplace: Remote with occasional onsite visits as required. Equal Opportunity Employer Statement 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 Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)), some roles may be subject to U.S. export controls for prospective employees from countries on embargo or sanctions status. For any 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’s start date. We will consider 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. #J-18808-Ljbffr