Intuitive · 1 week ago
Sr. Clinical Study Manager
Sunnyvale, CA
Full-time
Hybrid
Senior Level
$148K/yr - $212K/yr
5+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care. The Sr. Clinical Study Manager will lead clinical research activities, develop and execute strategies for clinical studies, and ensure compliance and quality throughout the study process.
Health CareManufacturingMedical Device
Responsibilities
Accountable for leading assigned clinical research activities
Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
Accountable for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful progress
Accountable for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan
Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites or in data listings to ensure regulatory and protocol compliance and overall accuracy
Liaise with sites and help in internal audit/inspection and ensure sponsor audit readiness
Liaise with external vendors and sites to negotiate contracts and budgets in partnership with the legal team and management
Track study progress and provide regular status reports
Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or help development of scientific publications
Track, process and manage site payments and help in study financial tracking by developing tracking tools as necessary
Organize and drive study meetings and other study activities as assigned
Mentor junior clinical study manager(s); provide guidance to CRAs and CTAs on monitoring and other study needs
Follow corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines) and proactively manage studies, following such guidelines and requirements
Conduct literature searches and familiarize with literature to stay informed and abreast of relevant scientific/clinical knowledge and/or to establish evidence gaps
Critically appraise scientific literature and write clinical summaries to assist research and the 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
For post-market research, partner with commercial groups (i.e., marketing) to know about market trends and utilize information to help of business goals through Clinical Affairs activities
For post-market research, provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research review (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 in partnership with management
Help regulatory submission and approval of pre-market clinical studies and 510k(s), accountable for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports)
Qualification
Required
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
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
Preferred
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
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
2025-12-11
2025-11-14
Company data provided by crunchbase