Intuitive Surgical Careers
Senior Clinical Affairs Project Manager - IDE
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182408
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
This position reports to the Manager, Clinical Affairs, and requires a candidate with extensive experience supporting evidence generation strategy and execution of premarket clinical studies. The Senior Clinical Project Manager will develop strategies for clinical and outcomes research studies to support regulatory approvals. As a senior member of the team, this role will be responsible for working with keys stakeholders to design and develop clinical protocols, and execute clinical studies (primarily pre market) with minimal supervision. The candidate will be required to work closely with data management and biostatistics to review and interpret results of clinical studies and to develop a clinical study report or support the development of clinical publications. The ideal candidate will have experience previously managing premarket studies in the United Stated and utilizing resources to research and scope a research topic and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience in reviewing, interpreting and summarizing clinical literature.
Roles and Responsibilities:
This position has responsibility and authority for:
• Responsible for leading pre-market clinical research activities
• Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (protocols, case report forms, informed consents, clinical trial agreements, monitoring plan), organizing IRB/EC submissions with follow thorough to ensure successful outcome
• Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
• Liaise with external vendors and sites to negotiate contracts and budgets
• Track study progress and provide status report on a weekly basis
• Participate in data analysis, interpretation and synthesis, instruction in order to develop clinical study report and /or support development of scientific publications
• Organize and lead major study meetings and activities
• Identify risks and escalate to key stakeholders as necessary
• Collaborate and mentor junior clinical project manager(s) and clinical research associates
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
• Conduct literature searches to stay abreast of scientific knowledge and to determine evidence gaps.
• Critically appraise scientific literature and write clinical summaries to assist research efforts and in development of clinical strategies and clinical investigational protocols.
• Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs leadership with continuous process improvement initiatives.
• Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
• Provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest) preparation of manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications.
Skill, Experience, Education & Training Requirements:
Competency Requirements: (Competency is based on: education, training, skills and experience) In order to adequately perform the responsibilities of this position the individual must have:
• Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) or Bachelor’s degree in a scientific/bioengineering field with 8-10+ years of experience in clinical affairs/research project management is preferred
• Previous experience implementing, supporting and managing premarket device trials
• Significant knowledge of clinical and outcomes research study design is necessary
• 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.
• Strong experience in protocol development , writing clinical section(s) for regulatory submission
• Possess knowledge of Good Clinical Practice ICH/GCP and other applicable regulations.
• Comfortable in a hospital environment, with experience working with nurses and surgeons (5-8 years) preferred
• Basic understanding of statistics, statistical methods, and design of experiment is a requirement
• Must be able to work effectively on cross-functional teams.
• Must be able to travel up to 10-20%
• Must be able to manage multiple projects
• Strong communication, presentation and interpersonal skills with high attention to detail and organization
• Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude)
• Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.