Experteer OverviewIn this role you enable efficient, high-quality clinical development by operating and evolving digital systems within a GxP framework. You work closely with the Group R&D Digital Solutions Manager to support Veeva Clinical Suite and ensure CSV and inspection readiness. You will drive system enhancements, data flows and automation to improve oversight, quality and trial efficiency. You balance hands-on system administration with collaboration across cross-functional teams to support study delivery. A strong focus on compliance, data integrity and continuous improvement anchors your impact and career growth.Retribuzione / BenefitsProvide day-to-day operational support and administration of R&D digital systems, focusing on Veeva Clinical Suite (eTMF/CTMS, CDMS, RTSM)Act as system administrator for assigned tools, including user access, roles and permissionsSupport data exports, integrations, issue resolution and user support across clinical studiesServe as operational contact for clinical teams to ensure systems enable study deliveryCoordinate Veeva releases, upgrades and configuration changes with impact assessment and stakeholder communicationContribute to evolution of digital solutions, supporting enhancements,



automation and data flow improvementsSupport initiatives for data-driven oversight, inspection readiness and operational efficiencyProvide operational project management support for R&D digital and innovation initiativesExecute and maintain CSV activities across the system lifecycle ensuring complianceMaintain validated state of GxP systems per GCP, Annex 11 and 21 CFR Part 11; author/execute validation docs with QASupport vendor management and coordination with system providers/service partnersAssist end-user training including material preparation and tracking training completionCommunicate effectively with technical, quality and business stakeholdersResponsabilità2–5 years of experience supporting digital systems in pharmaceutical or biotech R&DHands-on experience with Veeva Clinical systems (eTMF/CTMS, CDMS, RTSM)Practical experience in a GxP-regulated environment with CSV activitiesSolid understanding of GCP, Annex 11 and 21 CFR Part 11 in computerized systemsExperience supporting clinical studies from systems, data or operational perspectivesAbility to manage multiple activities/projects simultaneously with high attention to detailExperience working in cross-functional, international environments#J-18808-Ljbffr

📌 R&D Digital Solutions Specialist (Milano)
🏢 Experteer Italy
📍 Milano