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System One Holdings, LLC
Sr Manager Standards & SystemsSystem One Holdings, LLC • Plainsboro, NJ, US
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Sr Manager Standards & Systems

Sr Manager Standards & Systems

System One Holdings, LLC • Plainsboro, NJ, US
29 days ago
Job type
  • Full-time
Job description

Sr Manager Standards & Systems

Location: REMOTE Hours: 40.0

Responsibilities

  • Serve as the primary point of contact for activities related to "Rave Safety Gateway" implementation, developing, testing, and implementing complex edit checks and custom functions to support setup and integration.
  • Translate clinical and safety business requirements into efficient, structured programming logic.
  • Develop and maintain high-quality, reusable programming components to enhance the Genmab Global Library in compliance with data standards, processes, and governance.
  • Create VBA solutions for data validation and reconciliation across multiple Excel sheets to ensure accuracy, consistency, and compliance.
  • Validate Medidata Rave Safety Gateway (RSG) implementation components, ensuring alignment with specifications and data consistency.
  • Manage deliverables and coordinate with internal and external partners throughout the RSG implementation lifecycle.
  • Configure and maintain Rave Safety Gateway modules, including AE data flow and E2B format compatibility.
  • Develop and validate RSG Custom Functions (C#), and contribute to workflow definitions, troubleshooting, and system configuration.
  • Support development and updates for the Genmab Global CRF Library (GLIB), including form reuse, standard objects, and edit checks.
  • Perform cross-sheet validation, generate QC reports, and implement business rule checks in Excel VBA tools.
  • Own project deliverables, managing timelines, risks, issues, and stakeholder communications effectively.

Requirements

  • Bachelor's degree or equivalent experience in a relevant field.
  • Experience configuring and maintaining Medidata Rave Safety Gateway modules and workflows.
  • Strong Excel VBA programming skills, with proven experience in data validation and reconciliation.
  • Deep understanding of RSG custom functions (C#) programming and deployment.
  • Experience developing and maintaining Genmab Global CRF Library assets and standards.
  • Ability to troubleshoot, monitor, and optimize RSG logic across study phases.
  • Excellent stakeholder management, communication, and documentation skills.
  • Knowledge of E2B data formats and safety data flow processes.
  • Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced environment.
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Sr Manager Standards & Systems • Plainsboro, NJ, US

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