• Own and operate clinical systems as system owner, including access control, configuration, validation, and lifecycle management. • Ensure systems remain compliant with GxP regulations and internal SOPs, preserving data integrity and inspection readiness. • Lead requirements definition, solution design, and implementation planning with cross-functional stakeholders. • Provide Level-2 application support and vendor coordination for incident resolution and system enhancements. • Maintain and continuously improve system documentation, including validation deliverables, SOPs, and operational records. • Partner with Clinical Data Management to support data quality, flow, and operational needs. • Execute core system governance activities, including performance monitoring, upgrades, disaster recovery testing, access reviews, and license and vendor management. • Drive system adoption through training, documentation, and user enablement. • Support audits and regulatory inspections, including inspection responses, remediation, and CAPA closure. • Contribute to product roadmaps and release planning, balancing business value, regulatory risk, and technical feasibility. • Manage and maintain collaborative relationships with core business partners.