Sr Manager Standards & Systems

Sr Manager Standards & Systems

Location:

REMOTE

Hours:

40.0

• 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.

• 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.