R&D Digital Solutions Specialist

03 ago - Milano
Experteer Italy

ph3Experteer Overview /h3pIn 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 RD 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. /ph3Retribuzione / Benefits /h3ulliProvide day-to-day operational support and administration of RD digital systems, focusing on Veeva Clinical Suite (eTMF/CTMS, CDMS, RTSM) /liliAct as system administrator for assigned tools, including user access, roles and permissions /liliSupport data exports, integrations, issue resolution and user support across clinical studies /liliServe as operational contact for clinical teams to ensure systems enable study delivery /liliCoordinate Veeva releases, upgrades and configuration changes with impact assessment and stakeholder communication /liliContribute to evolution of digital solutions, supporting enhancements, automation and data flow improvements /liliSupport initiatives for data-driven oversight,



inspection readiness and operational efficiency /liliProvide operational project management support for RD digital and innovation initiatives /liliExecute and maintain CSV activities across the system lifecycle ensuring compliance /liliMaintain validated state of GxP systems per GCP, Annex 11 and 21 CFR Part 11; author/execute validation docs with QA /liliSupport vendor management and coordination with system providers/service partners /liliAssist end-user training including material preparation and tracking training completion /liliCommunicate effectively with technical, quality and business stakeholders /li /ulh3Responsabilità /h3ulli2–5 years of experience supporting digital systems in pharmaceutical or biotech RD /liliHands-on experience with Veeva Clinical systems (eTMF/CTMS, CDMS, RTSM) /liliPractical experience in a GxP-regulated environment with CSV activities /liliSolid understanding of GCP, Annex 11 and 21 CFR Part 11 in computerized systems /liliExperience supporting clinical studies from systems, data or operational perspectives /liliAbility to manage multiple activities/projects simultaneously with high attention to detail /liliExperience working in cross-functional, international environments /li /ul /p #J-18808-Ljbffr

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