Intuitive
5001 - 10000 employees
Founded 1995
⚕️ Healthcare Insurance
Healthcare Insurance • Medical Devices
Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.
Senior Clinical Study Manager
Job not on LinkedIn
🔥 2 hours ago
🏄 California – Remote
đź’µ $151.7k - $218.3k / year
⏰ Full Time
đźź Senior
🧪 Clinical Research
🦅 H1B Visa Sponsor
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Intuitive
5001 - 10000 employees
Founded 1995
⚕️ Healthcare Insurance
Healthcare Insurance • Medical Devices
Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.
đź“‹ Description
• This 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.
🎯 Requirements
• Previous experience implementing, supporting and managing medical device trials • Significant knowledge of clinical and/or outcomes research study design • Strong experience in protocol and ICF development, writing clinical section(s) for regulatory submission • Strong experience in conducting literature searches, reviews and appraisal of the scientific data • Excellent ability to interact with physicians and other professionals inside and outside the company • Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental understanding of clinical research and monitoring requirements • Experience negotiating clinical research contracts and budgets • Must be able to work effectively on cross-functional teams • Must be able to travel 25-40% or depending on business requirements • Must be able to manage multiple projects and/or balance competing priorities • Strong communication, presentation and interpersonal skills with high attention to detail and organization • Ability to learn quickly, adapt to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects • Ability to lead project team consisting of CRAs and CTAs and support management with relevant study updates • Exhibits strong work ethic to help meet aggressive timelines or multiple projects when necessary with a problem-solving mindset
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities
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