Research Science Management

Job Description

Primary Function of Position:

The purpose of this job function is to serve as a Scientific Research Program Manager (SRPM) in the Digital Business Unit to support research projects, within the United States and across the world, to demonstrate the performance and impact of Intuitive Surgical’s Digital products and services. This role has responsibility to oversee initiation, progress, and conduct of evidence-generation studies to include those conducted by internal scientific teams as well as Intuitive-sponsored studies and studies done in collaboration with external research partners. The SRPM serves as a contact to all parties involved in projects, internal and external.

Roles & Responsibilities:

• Manage and execute a portfolio of internal and external collaborative research studies and evidence-generation activities for Intuitive Surgical’s Digital products and services, with or without the assistance of research coordinator(s)
• Be responsible for the management of the research studies including project development, budgeting, investigator selection, analysis of potential participant recruitment, preparation of study related documents (e.g., protocols, case report forms, informed consents, research agreements), and management of Institutional Review Board and / or Ethics Committee submissions with follow through to ensure a successful outcome
• Work with data management professionals and statisticians as needed for assigned projects
• Maintain study documentation (e.g., correspondence, documentation required by the U.S Code of Federal Regulations (CFR), deviations, budget information)
• Plan and manage the project timelines to ensure research studies are conducted in a timely manner and within the project budget
• Proactively anticipate and communicate concerns, issues, and delays in the project and develops risk assessment and contingency plans
• Prepare project status updates and power point presentations for reporting to internal and external stakeholders for assigned projects
• Prepare reports in support of external and internal steering or advisory committees as needed
• Manage publication development, submission, and response to peer review for related to research studies
• Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and international guidelines)
• Ensure audit readiness of research projects to relevant regulatory and legal standards
• Management of Contract Research Organization (CRO) or independent research service providers (e.g., identification of suitable partner(s), development of contracts or statements of work, and management of stakeholders to ensure project success)
• Facilitate participation in meetings and reporting with adherence with Intuitive Surgical policies
• Review and develop internal processes (e.g., SOPs)
• Build, nurture, and maintain relationships with external research partners and stakeholders, which may include but are not limited to 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

Qualifications

Skills, Experience, Education, & Training:

• Bachelor’s degree or equivalent in life sciences, medicine, medical sciences, engineering, or computer/data science (required); graduate degree (preferred)
• Experience working in the healthcare technology industry in a clinical affairs or scientific research function with evidence of full project management responsibility for at least three years (required)
• Five years of experience in the management of research, with experience in clinical research management in both academic/hospital and industry settings (preferred)
• Knowledge of applicable clinical research and medical device regulations and guidelines including GCP, ISO-14155, MEDDEV, MDR and Data protection rules (required)
• Protocol and CRF development experience (required)
• Excellent organizational skills with the ability to manage multiple projects with competing priorities (required)
• Ability to manage a minimum of three to five research projects across different surgical disciplines and/or products (required)
• Excellent communication and interpersonal skills with strong negotiation abilities (required)
• Ability to work independently and across teams whilst keeping open communication with key stakeholders (required)
• Strong numerical and literary analytical skills with the ability to assess data and literature
• Experience reviewing data sets to evaluate data quality
• Experience with studies of health information technologies including artificial intelligence is an advantage
• Ability to manage CROs or external consultants
• Ability to manage research coordinators or other research staff in the execution of research studies
• Experience of publishing research (own or in industry capacity) is an advantage
• Excellent problem-solving skills and initiative
• English language required, a second language is an advantage

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