Senior Staff Clinical Data Systems Specialist

What will you do

• Lead Clinical Database Programming activities.
• Manage administration of the Rave URL activities: Report Administration, eLearning, User Roles and Core Configuration.
• Provide technical support for Rave study development, Rave URL modules, and site management/user access within Medidata Client Division.
• Lead development of study database development, including but not limited to, programming of clinical database according to CRF Specifications and programming of edit checks (edit checks, derivations, and custom functions) according to Edit Check Specifications.
• Support Stryker Neurovascular Global Library by programming forms, edit checks (edit checks, derivations, and custom functions) according to Stryker NV data collection standards.
• May serve as system administrator to grant user and site access using Medidata Cloud Administration for Rave (EDC and Modules), Coder, RTSM and MMI (Imaging).
• Follow Stryker standard processes and maintain proper documentation in performance of Medidata product administration and development activities within the Medidata Client Division and Rave URL.

What you need

Required

• Bachelor’s Degree in technical or scientific discipline
• 8+ years of clinical database programming experience in CRO, medical device, or pharma
• Proven expertise as a Medidata Rave super user, including URL management, database build, amendment manager, quick publish, core configuration, testing, and validation for global clinical trials
• Medidata Rave 5.6.4 Certified Study Builder
• C# programming
• Global Library Development
• Hands-on experience with clinical studies, including EDC design, CRF development, edit checks, and UAT
• Strong knowledge of data collection, reconciliation, processing, coding, reporting, and validation across clinical trial data workflows

Preferred

• Medidata: eCOA, TSDV, Rave Web Services (RWS)
• Zelta EDC2 Certified Basic Designer
• Base SAS
• Previous experience with complex, global trials