Qualifications: Fully Remote Work Schedule This person will serve as the **primary point of contact** for activities related to **Rave Safety Gateway** implementation. This role will develop, test, and implement **complex edit checks** and **custom functions** to support Rave Safety Gateway setup and integration and is expected to translate **clinical and safety business requirements** into efficient, structured programming logic. This role will regularly contribute to ongoing enhancements of the **Genmab Global Library** by developing and maintaining high-quality, reusable programming components and ensure compliance with Genmab’s data management standards, processes, and governance frameworks. Additionally, the role will develop VBA solutions to validate and reconcile data across multiple Excel sheets, ensuring accuracy, consistency, and compliance with defined standards. A key responsibility is to validate Medidata Rave Safety Gateway (RSG) implementation components in ALS/Excel format, ensuring alignment with specifications and data consistency across files. The contractor will also actively manage deliverables and coordinate cross-functionally with internal and external partners throughout the RSG implementation lifecycle. Responsibilities: **Technical Expertise** **Medidata Rave Safety Gateway Module **: Hands-on experience configuring and maintaining Rave Safety integrations, including AE data flow to Safety systems (e.g., E2B format compatibility and data consistency checks). • **RSG Workflow Knowledge**: • In-depth understanding of RSG workflows, including mapping, setup, and management in Rave. • Ability to define, monitor, and troubleshoot RSG logic across various study phases. • **RSG Custom Function (C#) Programming**: • Hands-on experience in writing, validating, and deploying Custom Functions for RSG workflows. • Familiarity with dynamic RSG programming aligned with protocol-specific and safety requirements. • **Global Library Development and Usage Knowledge**: • Experience in developing and maintaining Genmab Global CRF Library (GLIB) assets, including form reuse, standard object implementation, and global edit checks. • Ability to contribute to or manage updates to GLIB based on evolving standards. • Develop and maintain Excel VBA tools for data validation and QC • Perform cross-sheet and cross-workbook validation to identify inconsistencies, missing data, and formatting issues • Validate RSG ALS files, including mappings, configurations, and data structures • Implement QC checks based on business rules and standards • Generate QC reports with clear, actionable findings • Project Management responsibilities by owning and managing deliverables, timelines, and dependencies, coordinating across internal and external partners, tracking issues/risks and drive resolution, lead communications and provide status updates • Strong Excel VBA programming experience (core requirement) • Proven experience in data validation, QC, or reconciliation across complex Excel files • Strong analytical skills and attention to detail • Effective communication and stakeholder management * *Process and Standards Alignment** - Consistently apply and enforce GLIB standards throughout the development lifecycle. - Proactively identify issues and collaborate effectively with cross-functional teams (e.g., Data Management, Safety, Biostatistics, and DM Service Providers). - Strong documentation and communication skills, including the ability to manage specifications, programming deliverables, and validation reports.
