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Senior Clinical Study Manager

Intuitive
Sunnyvale, USA
Full-time
Senior · 10+ years experience
Remote
Discovered 1 weeks ago
gcp

Full Job Posting

Required Skills and Experience

  • Previous experience implementing, helping and managing medical device trials Significant knowledge of clinical and/or outcomes research study design
  • Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
  • Proven 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
  • Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
  • Experience negotiating clinical research contracts and budgets
  • Must be able to work effectively on cross-functional teams
  • Must be able to travel 25-40% or based on business requirements
  • Must be able to manage multiple projects and/or manage different priorities
  • Proven communication, presentation and relational skills with high attention to detail and organization
  • Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)
  • Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updates
  • Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset
  • Required Education and Training
  • Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training.
  • Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred
  • Knowledge of statistics, statistical methods, and design of experiment is highly preferred

Preferred Skills and Experience

  • Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred
  • Knowledge of statistics, statistical methods, and design of experiment is highly preferred
  • Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
  • Intuitive is an Equal 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.
  • Mandatory Notices
  • U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
  • Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
  • For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
  • We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
  • Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
  • This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.
  • Accommodation & Accessibility Notice:
  • Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [email protected].
  • We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
  • It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.
  • Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
  • The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life.
  • The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.
  • If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

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