Scientific Research Program Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the Scientific Research Program Manager for the da Vinci Cardiac Surgery Program.

• Formulate a strategy for evidence generation within the Cardiac Surgery Program.

• Assist with research initiatives that showcase the effectiveness and impact of Intuitive Surgical's da Vinci platforms, products, and services both in the U.S. and internationally.

• Supervise the initiation, progress, and execution of internal, sponsored, and externally collaborative evidence-generation studies.

• Work together with program leaders and cross-functional stakeholders to identify evidence gaps, prioritize evidence needs, and create evidence-generation plans.

• Oversee a portfolio of internal and external collaborative research studies and related evidence-generation activities.

• Manage studies throughout their entire lifecycle, including development, budgeting, investigator selection, participant recruitment analysis, study documentation, and IRB/Ethics Committee submissions.

• Collaborate with data management experts and statisticians; maintain study documentation; and manage timelines and budgets effectively.

• Identify and communicate project-related concerns, delays, and risks; devise contingency plans; and prepare status updates, presentations, and reports.

• Oversee the development, submission, and peer-review response process for publications.

• Ensure adherence to corporate SOPs, GCP, as well as U.S. and international regulatory standards; maintain readiness for audits.

• Manage CROs and independent research service providers, including partner selection, contracts or statements of work, and stakeholder relations.

• Assist in the formulation of internal research processes and SOPs.

• Establish and sustain relationships with research partners, surgeon key opinion leaders, hospital stakeholders, professional societies, and healthcare technology partners.

⛳️ Requirements

• A minimum of five years of experience in an academic environment or the healthcare technology sector in a clinical affairs or scientific research role, with full project management accountability.

• Comprehensive knowledge of clinical research and medical device regulations and guidelines, including GCP, ISO 14155, MEDDEV, MDR, and data protection standards.

• Proven experience in developing research protocols and case report forms (CRFs).

• Capability to manage three to five research projects across various surgical disciplines and/or products.

• Excellent organizational, communication, interpersonal, negotiation, quantitative, literature analysis, problem-solving, and initiative skills.

• Ability to work independently and collaborate effectively across teams.

• Proficiency in assessing data and scientific literature, as well as reviewing data sets for quality.

• Experience managing CROs, external consultants, research coordinators, or other research personnel.

• Proficiency in the English language is required.

• A bachelor's degree or equivalent in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.

• Willingness to travel 25%-50% of the time.

• The role may necessitate presence in hospital and surgical/operating room settings.

• Preferred qualifications include a graduate degree; five years of research management experience in both academic/hospital and industry contexts; involvement in health information technology studies, including artificial intelligence; research publication experience; and proficiency in a second language.

• Current proof of vaccination against certain diseases, including COVID-19, may be required.

• Some positions may be subject to U.S. export-control licensing or a Technology Control Plan.

🏝️ Benefits

• Remote work options; employees are required to be onsite only when requested by their supervisor.

• Competitive compensation packages that include incentives, benefits, and equity options.

• Reasonable accommodations available for qualified individuals with disabilities.

• Potential coverage/requirements for vaccinations against certain diseases, including COVID-19.

• Equal employment opportunity protections provided.

• Fair chance consideration for applicants with arrest and conviction histories.