Intuitive Surgical Careers

Clinical Data Manager

US-CA-Sunnyvale, California
Clinical Affairs


Job Description

Job: Clinical Affairs
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 183633

Description

Company Description:

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:

Responsibilities

• 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.
Qualifications

Requirements:

• 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.