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3 days ago
The System Administration Support role involves overseeing Rave EDC user access and managing Classic Rave and Rave EDC system upgrades for all Rave URLs. This requires coordinating cross-functional activities to manage the Rave EDC Platform effectively.
Principal Responsibilities- Provide technical support for clinical trial platform technologies related to the Rave EDC System, ensuring operational delivery of system activities supporting EDC platform upgrades.
- Work with the EDC vendor to translate business issues/requirements into technical solutions, driving continuous improvement in Rave User Access and EDC release validation processes.
- Manage Rave EDC FMT meetings, including agenda setting and meeting minutes, maintaining standard business processes within GDO Systems to ensure regulatory compliance.
- Coordinate and oversee Rave User Access for all studies across all Rave URLs, collaborating with cross-functional teams for testing downstream systems affected by Classic Rave and Rave EDC releases.
- Evaluate potential use of other EDC systems, e.g., Veeva System, providing technical and business process input for automation and new technology adoption.
- Serve as a liaison between R&D stakeholders and systems for Rave access and design of new functionality due to business or regulatory changes, responding to R&D stakeholder inquiries related to Rave User Access and managing the EDC mailbox.
- Master's degree and 4 to 6 years of related experience, demonstrating strong technical and analytical skills with the ability to manage multiple projects.
- Bachelor's degree and 6 to 8 years of related experience, showcasing exceptional attention to detail and accuracy in deliverables, with proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Diploma and 10 to 12 years of related experience, highlighting ability to work independently and proactively in a fast-paced environment, with familiarity with virtual collaboration tools (e.g., Teams, WebEx).
- Management and operational oversight of GDO systems, platforms, and tools (e.g., EDC), ensuring quality and timely operational delivery of system activities supporting EDC platform upgrades.
- Lead or participate in the development, review, and implementation of processes, SOPs, and policies affecting GDO, optimizing Rave EDC release validation using AI and automated technologies.
- Excellent verbal and written communication skills, high degree of professionalism and interpersonal skills, and resilience, discretion, and ability to thrive under pressure.
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