At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.
As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.
We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.
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 Clinical Study Manager will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals. As a member of the team, this role will be responsible for working with key 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 clinical research associates, data management and biostatistics to review and interpret results of clinical studies and to develop clinical study reports or support the development of clinical publications. The ideal candidate will have experience previously managing premarket studies in the United States 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.
Roles & Responsibilities:
- Responsible for leading pre-market clinical research activities
- Collaborate with internal stakeholders and KOLs to develop and review study design and concepts, prepare 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), 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 regular status report
- Work closely with Biostats on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or support development of scientific publications.
- Organize and lead major study meetings and activities
- Collaborate and mentor junior clinical study 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 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)
- Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications.
- Support regulatory submission and approval of pre-market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports).
Skills, Experience, Education, & Training:
- Minimum Education: Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) with a minimum of 2-3 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 5 years of experience in clinical research is preferred
- Previous experience implementing, supporting and managing premarket device trials
- Significant knowledge of clinical and outcomes research study design
- 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, experience working with nurses and surgeons 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
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift : Shift 1 - Day
Travel : Yes, 25 % of the Time
Travel Requirements: Yes, 25 % of the Time Shift: Shift 1 - Day
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