Senior Clinical Study Manager

🔥 3 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $128.9k - $218.3k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Intuitive

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1995

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.

📋 Description

• Develop and execute strategies for clinical and outcomes research studies supporting regulatory approvals and strategic evidence initiatives • Design and develop clinical protocols and execute pre-market or post-market clinical studies with minimal supervision • Collaborate with CRAs, CTAs, data management, biostatisticians, investigators, KOLs and internal stakeholders • Plan and execute studies, including site selection, patient recruitment projections, site start-up, enrollment and follow-up • Create protocols, case report forms, informed consents, clinical trial agreements and study reports • Organize IRB/EC submissions and follow through to ensure study progress • Conduct site qualification, site initiation, interim monitoring and site close-out visits, both onsite and remotely • Monitor studies for regulatory and protocol compliance and data accuracy • Complete source data verification in EDC systems, case report forms or data listings • Support internal audits, inspections and sponsor audit readiness • Negotiate contracts and budgets with external vendors and sites in partnership with legal and management • Track study progress, provide status reports and manage site payments and study financial tracking • Work with biostatisticians on data analysis, interpretation and synthesis for clinical study reports and scientific publications • Organize study meetings and mentor junior clinical study managers • Provide guidance to CRAs and CTAs • Follow corporate SOPs, GCP and U.S. and international regulatory guidelines • Conduct literature searches, critically appraise scientific literature and write clinical summaries • Review and revise Clinical Operations SOPs for process improvement • Partner with commercial groups on post-market research and provide scientific expertise to Health Economics and Outcomes Research • Work with investigators to prepare manuscripts, abstracts, slide presentations and posters • Support regulatory submissions and approvals for pre-market studies and 510(k)s, including responses to regulatory questions

🎯 Requirements

• 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 and writing clinical sections for regulatory submissions • Proven experience conducting literature searches, reviews and appraisal of scientific data • 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 • Ability to work effectively on cross-functional teams • Ability to travel 25–40% or based on business requirements • Ability to manage multiple projects and shifting priorities • Strong communication, presentation and relational skills with high attention to detail and organization • Ability to learn quickly, tailor to shifting requirements and self-educate on surgical specialties • Ability to drive project teams consisting of CRAs and CTAs • Solid work ethic and problem-solving mindset • Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with 5 years of clinical research experience, or bachelor's degree in a scientific/bioengineering field with 8 years of clinical research experience, or 10 years of clinical research experience with relevant training • Experience working in a hospital environment and with nurses and surgeons preferred • Knowledge of statistics, statistical methods and design of experiments highly preferred • Current proof of vaccination against certain diseases, including COVID-19, may be required • Candidates must comply with applicable U.S. export-control requirements where applicable

🏖️ Benefits

• Remote work; employees come onsite when requested by the leader • Incentives • Benefits • Equity • Reasonable accommodations for qualified individuals with disabilities • Potential vaccination requirement, including COVID-19 vaccination, depending on the role or customer requirements