R&D Digital Solutions Specialist

Eusa Pharma; Spoleto; In loco; EUR 65.000 - 95.000; Tempo pieno

Descrizione del lavoro

La posizione di R&D Digital Solutions Specialist presso Eusa Pharma supporta l’uso operativo dei sistemi digitali in sviluppo clinico, con focus su Veeva e CSV in ambiente GxP.

In stretta collaborazione con il Group R&D Digital Solutions Manager, si occuperà di validazione, consentendo miglioramenti dei processi e delle data‑flows per le trial. Si richiede esperienza con Veeva e sistemi correlati e attenzione ai requisiti di compliance.

Competenze

• Laurea triennale/magistrale in Life Sciences, Informatica, Ingegneria o disciplina affine.
• Formazione in GxP/CSV o certificazioni fortemente preferite.
• Esperienza pratica con sistemi Veeva Clinical (eTMF/CTMS, CDMS, RTSM) è un plus.
• Preferenza per esperienza in piattaforme cliniche simili (Medidata, ecc.) e configurazione di sistemi.

Mansioni

• Supporto operativo giorno‑per‑giorno dei sistemi digitali R&D e gestione accessi utenti.
• Gestione rilasci e cambi di configurazione, con impatto su –validazione e comunicazione agli stakeholder.
• Supporto alle attività di CSV e conformità in ambiente GxP e GMP.
• Coordinamento con fornitori e partner per training e onboarding degli utenti.
• Interazione con team clinici per assicurare che i sistemi supportino efficacemente lo studio.

Conoscenze

Veeva eTMF/CTMS

CSV

GxP compliance

Validation

Cross-functional collaboration

Project management

Clinical operations support

Formazione

Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering or equivalent scientific/technical discipline

Strumenti

Veeva Vault

eTMF/CTMS tools

CDMS

RTSM

Descrizione del lavoro

Descrizione dell’offerta di lavoro Job PurposeThe R&D 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 R&D 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.

Key Responsibilities

Digital Systems Operations & Clinical Study Enablement - Provide day‑to‑day operational support and administration of R&D 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 R&D 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 R&D 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.

Required Education

• Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering or equivalent scientific/technical discipline.
• Formal training or certification in GxP / CSV / Quality Systems is a strong plus.
• Hands‑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.
• While 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.

Required Skills and Experience

• 2–5 years of experience supporting digital systems within Pharmaceutical or Biotech R&D, with exposure to clinical trial environments.
• Hands‑on operational experience with Veeva Clinical systems, particularly eTMF/CTMS, CDMS and RTSM.
• Practical experience working in GxP-regulated environments, including execution or support of Computer System Validation activities.
• Solid understanding of GCP, Annex 11 and 21 CFR Part 11 as applied to computerized systems.
• Experience supporting clinical studies from a systems, data or operational perspectivewithin Pharmaceutical or Biotech R&D. xysqume - Demonstrated ability to manage multiple activities and projects simultaneously, with strong attention to detail.
• Experience working in cross‑functional, international environments.

Technical Competencies

• clinical systems knowledge (eTMF/CTMS, CDMS, RTSM)
• change control and release management in validated environments
• basic understanding of clinical trial processes and data flows
• Computer System Validation (CSV) methodologies and documentation
• GxP compliance for computerized systems
• Project management tools and methodologies (formal certification is a plus)

Required Behaviours and Competencies

• Strong execution and delivery mindset
• High level of accuracy, reliability and accountability
• Ability to work autonomously while contributing to broader digital strategy
• Structured, pragmatic and quality-oriented approach
• Clear communication with technical and non-technical stakeholders
• Curiosity and openness towards innovation and continuous improvement, with problem‑solving attitude

Required Languages

English: Fluent (written and spoken)