Principal Clinical Data Systems Specialist (Remote)

Stryker • Trenton, NJ

1d • $115,600 - $245,800 • Remote

About The Position

Stryker is seeking a Principal Clinical Data Systems Specialist to join our Neurovascular division. This is a remote role based anywhere within the United States. As the Principal Clinical Data Systems Specialist you will provide data management expertise and support to Core teams. The successful candidate will have good knowledge of clinical data management systems, as well as global regulatory and industry rules and guidance (i.e., ICH, GCP). This role is responsible for supporting the Stryker Neurovascular Medidata Rave URL and database build activities. This position may train Clinical Data Management team members and may support activities of Clinical Data Management staff, CRO and Database Vendors.

Requirements

• Bachelor’s degree
• 8+ years of clinical data management experience in medical device or pharma
• Proven expertise as a Medidata Rave super user, including URL management, database build, configuration, testing, and validation for global clinical trials
• Hands-on experience with PMV 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
• Deep understanding of clinical data management systems and regulatory standards (ICH GCP, ISO14155, Good Data Management Practices, IDE, HIPAA, GDPR, 21 CFR Part 11)

Nice To Haves

• Master's Degree in a technical or scientific discipline
• Medidata Rave 5.6.4 Certified Study Administrator, Medidata Rave 5.6.4 Certified Study Builder
• Working knowledge of SAS programming, electronic data capture, and XML
• C# programming
• Medidata Imaging Platform
• Previous experience with complex, global trials

Responsibilities

• 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.
• Lead Clinical Data and SAS Programming activities.
• Create and maintain Clean Patient Trackers, dashboards and operational reports.
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees