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Intuitive Surgical

Builds robots for minimally invasive surgery

Research Science Management

Clinical Research OperationsPosted on Nov 13
Full-timeSunnyvale, CA, USA$132k - $223.5k

About the Job

Requirements

  • A bachelor's degree or equivalent in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.
  • At least five years of experience in an academic setting or healthcare technology industry in a clinical affairs or scientific research function, with evidence of full project management responsibility.
  • Knowledge of applicable clinical research and medical device regulations and guidelines, including Good Clinical Practice, ISO 14155, MEDDEV, MDR, and data protection requirements.
  • Experience developing research protocols and case report forms.
  • Ability to manage at least three to five research projects across different surgical disciplines and/or products, including competing priorities.
  • Strong organizational skills.
  • Strong communication, interpersonal, and negotiation skills, with the ability to manage work autonomously and collaborate across teams while maintaining open communication with key stakeholders.
  • Strong quantitative and literature analysis skills, including the ability to assess data and scientific literature and review data sets for data quality.
  • Ability to manage Contract Research Organizations, external consultants, research coordinators, or other research staff in executing research studies.
  • Strong problem-solving skills and initiative.
  • English-language proficiency is required.
  • Ability to travel 25%-50% of the time.
  • Work may require presence in hospital and surgical or operating room environments.

Responsibilities

  • Collaborate with da Vinci and Multiport program leaders and cross-functional evidence stakeholders to identify evidence requirements and gaps, align on evidence priorities, and develop evidence strategies and plans.
  • Manage and execute a portfolio of internal and external collaborative research studies and evidence-generation activities for Intuitive Surgical's da Vinci platforms, products, and services, with support from research coordinators as applicable.
  • Manage research studies across the study lifecycle, including project development, budgeting, investigator selection, analysis of potential participant recruitment, preparation of study-related documents such as protocols, case report forms, informed consents, and research agreements, and management of Institutional Review Board and/or Ethics Committee submissions through successful outcome.
  • Collaborate with data management professionals and statisticians as needed, maintain required study documentation, and plan and manage project timelines and budgets to support timely execution.
  • Proactively identify and communicate project concerns, issues, and delays; develop risk assessments and contingency plans; and prepare project status updates, presentations, and reports for internal and external stakeholders and steering or advisory committees.
  • Manage publication development, submission, and responses to peer review related to research studies.
  • Ensure compliance with corporate requirements such as standard operating procedures and applicable regulatory requirements such as Good Clinical Practice and U.S. and international guidelines, and maintain audit readiness to relevant regulatory and legal standards.
  • Manage Contract Research Organizations and independent research service providers, including partner identification, contract or statement-of-work development, and stakeholder management; facilitate meetings and reporting in accordance with company policies; and support review and development of internal research processes such as standard operating procedures.
  • Build, nurture, and maintain relationships with external research partners and stakeholders, including surgeon key opinion leaders, operating room staff, hospital and health system administrative and technology leaders, surgical and scientific professional society leaders, and healthcare technology industry partners.

Desired Qualifications

  • Industry research management experience.
  • A graduate degree in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.
  • Five years of experience managing research, including clinical research management experience in both academic or hospital and industry settings.
  • Experience with studies of health information technologies, including artificial intelligence.
  • Experience publishing research in an academic or industry capacity.
  • Proficiency in a second language.

About the Company

Intuitive Surgical

Builds robots for minimally invasive surgery

Intuitive Surgical makes da Vinci robots that let surgeons operate through a few small incisions, and Ion, a robot that reaches deep into the lungs to take tissue samples. In 2000, da Vinci became the first robotic system cleared by the FDA for general laparoscopic surgery, meaning keyhole operations in the abdomen. A surgeon sits at a nearby console and steers robotic arms holding a 3D camera and wristed instruments, which turn hand movements into smaller, steadier motions. Hospitals buy or lease the robots, then keep paying for the instruments used in each operation and for service. Intuitive was founded in 1995 to commercialize robotic surgery research from SRI International and is based in Sunnyvale, California.

Company size
10,001+
Company stage
IPO
Headquarters
Sunnyvale, CA
Founded
1995

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