Intuitive Surgical Careers
Clinical Data Manager
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183633
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Position Summary / Primary Responsibilities:
Qualifications• Develop clinical study data specifications, including CRF design, user requirements, edit checks and develop query logic• Provide clinical data management support for study operations and analysis groups including the following. Assist in defining and creation of data listings, data specifications and/or process data transfers in preparation for statistical review.• Experience with validation of EDC’s at a study level. Ideally would have experience with study requirements, test scripts, and UAT documentation.• Administration of existing EDC systems for multiple studies• Managing data DM activities for multiple studies simultaneously in a dynamic environment• Training users on EDC systems. Includes create of training documentation and running training sessions for end users.• Working knowledge of Clinical database applications such as EDC and CTMS.• Data cleaning and review of clinical data. Including query management and data listing review.
• Proven experience in data management role• Excellent understanding of data administration and management functions (collection, analysis, data review process, etc.)• Medical knowledge as pertaining to medical devices for surgery. This will help to understand CRF design and purpose and interpret Study manager/protocol requirements to efficient EDC design.• Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.• Excellent communication skills and working with multiple teams on multiple projects• Proficient in MS Office (Excel, Powerpoint, Word etc.)• Proficiency with SAS software is desired• BSc/BA in a scientific or medical field• Minimum 2-5 years’ experience in data management role
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.