Sr Manager Standards & Systems

Job Title: Sr Manager Standards & Systems

Location: REMOTE

Hours: 40.0

Overview

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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-

#LI-

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.