Principal Clinical Data Systems Specialist; Remote

Principal Clinical Data Systems Specialist (Remote) page is loaded## Principal Clinical Data Systems Specialist (Remote) locations:
Trenton, New Jersey time type:
Full time posted on:
Posted Todayjob requisition :
R553067

Work Flexibility:
Remote 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.

** What will you do
*** 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 you need*
* ** Required
* ** 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, ISO
14155, Good Data Management Practices, IDE, HIPAA, GDPR, 21 CFR Part 11)
** Preferred
* ** 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 $ - $ salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage : 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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