Intuitive Autonomy
Senior Clinical Study Manager
Sunnyvale, CA, United States · Senior · Contract
Sponsorship not specified$25k-$40kDetected 20 hours ago
GCPData AnalysisStatisticsAuditingProcess ImprovementCustomer SuccessClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchExperimental DesignLeadershipCommunicationCollaborationProblem SolvingPublic SpeakingInternal AuditGxP
About the role
- 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.
Responsibilities
- Collaborate with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
- Liaise with sites and support in internal audit/inspection and ensure sponsor audit readiness
- Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or support development of scientific publications
- Track, process and manage site payments and support in study financial tracking by developing tracking tools as necessary
- Organize and lead study meetings and other study activities as assigned
- 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
- For post-market research, collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
Requirements
- Must be able to work effectively on cross-functional teams
- Must be able to travel 25-40% or depending on business requirements
Skills
- It started with a simple idea: what if surgery could be less invasive and recovery less painful?
- If applicable, candidates will be notified and instructed on any requirements for these purposes.
- This position may be filled at a different job level than listed here depending on
- Compensation will be based primarily on the job level at which the role is filled and the
- We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and eq
Compensation
- $25k-$40k
Benefits
- Previous experience implementing, supporting and managing medical device trials Significant knowledge of clinical and/or outcomes research study design
Company info
- 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.
Visa & Work Authorization
- Liaise with sites and support in internal audit/inspection and ensure sponsor audit readiness
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