R&D Digital Solutions Specialist
Pubblicato il 29-08-2026 - EUSA Pharma in Spoleto
ppDescrizione dell’offerta di lavoro Job PurposeThe RD Digital Solutions Specialist supports the operation, compliance and continuous evolution of digital systems that enable efficient, high quality clinical development across the Group. Working closely with the Group RD Digital Solutions Manager, the role combines hands‑on operational ownership of Veeva Clinical systems with responsibility for maintaining Computer System Validation (CSV) and inspection readiness within a GxP‑regulated environment. Beyond day‑to‑day system operations, the position contributes to the future development of digital and data‑driven solutions in Clinical Operations, supporting system enhancements, process optimisation and the adoption of innovative approaches that improve oversight, quality and efficiency in clinical trials. /p h3Key Responsibilities /h3 pDigital Systems Operations Clinical Study Enablement - Provide day‑to‑day operational support and administration of RD digital systems, with primary focus on Veeva Clinical Suite (eTMF/CTMS, CDMS, RTSM). - Act as business/system administrator for assigned systems, including user access management, role configuration and permissions for internal and external users. - Support the operational use of Veeva systems across clinical studies, including data exports, integrations, issue resolution and user support. - Serve as a key operational contact for clinical teams, ensuring systems effectively support study delivery. System Lifecycle, Innovation Continuous Improvement - Coordinate Veeva releases, upgrades and configuration changes, including impact assessment, validation activities and stakeholder communication. - Contribute to the evolution of digital solutions within Clinical Operations, supporting system enhancements, automation opportunities and improved data flows. - Support initiatives that strengthen data‑driven oversight, inspection readiness and operational efficiency across clinical trials.
- Provide operational project management support for RD digital and innovation initiatives. Compliance, CSV Inspection Readiness - Execute and maintain Computer System Validation (CSV) activities across the system lifecycle, ensuring systems remain compliant and fit for purpose. - Maintain the validated state of GxP systems in line with GCP, Annex 11 and 21 CFR Part 11 requirements. - Author, execute and maintain validation documentation and system records in collaboration with Quality Assurance. - Support Quality Assurance during audits and regulatory inspections related to RD computerized systems. Vendor, Training Stakeholder Support - Support vendor management activities, including coordination with system providers and service partners. - Support end‑user training activities, including preparation of training materials and tracking of training completion. - Communicate effectively with technical, quality and business stakeholders. /p h3Required Education /h3 ul liBachelor's or Master's degree in Life Sciences, Computer Science, Engineering or equivalent scientific/technical discipline. /li liFormal training or certification in GxP / CSV / Quality Systems is a strong plus. /li liHands‑on experience and/or formal training on Veeva Clinical systems (e.G.Può ottenere maggiori dettagli sulla natura di questa posizione e sui requisiti per i candidati leggendo quanto seguito.Veeva Vault eTMF/CTMS, CDMS, RTSM) is considered a strong plus. /li liWhile hands‑on experience with Veeva Clinical systems is a strong plus, experience with other clinical trial platforms (e.G.Medidata, CluePoints or equivalent systems),
including system configuration, implementation and process setup, is also highly valued. /li /ul h3Required Skills and Experience /h3 ul li2–5 years of experience supporting digital systems within Pharmaceutical or Biotech RD, with exposure to clinical trial environments. /li liHands‑on operational experience with Veeva Clinical systems, particularly eTMF/CTMS, CDMS and RTSM. /li liPractical experience working in GxP-regulated environments, including execution or support of Computer System Validation activities. /li liSolid understanding of GCP, Annex 11 and 21 CFR Part 11 as applied to computerized systems. /li liExperience supporting clinical studies from a systems, data or operational perspectivewithin Pharmaceutical or Biotech RD. xysqume - Demonstrated ability to manage multiple activities and projects simultaneously, with strong attention to detail. /li liExperience working in cross‑functional, international environments. /li /ul h3Technical Competencies /h3 ul liclinical systems knowledge (eTMF/CTMS, CDMS, RTSM) /li lichange control and release management in validated environments /li libasic understanding of clinical trial processes and data flows /li liComputer System Validation (CSV) methodologies and documentation /li liGxP compliance for computerized systems /li liProject management tools and methodologies (formal certification is a plus) /li /ul h3Required Behaviours and Competencies /h3 ul liStrong execution and delivery mindset /li liHigh level of accuracy, reliability and accountability /li liAbility to work autonomously while contributing to broader digital strategy /li liStructured, pragmatic and quality-oriented approach /li liClear communication with technical and non-technical stakeholders /li liCuriosity and openness towards innovation and continuous improvement, with problem‑solving attitude /li /ul h3Required Languages /h3 pEnglish: Fluent (written and spoken) /p /p #J-18808-Ljbffr