R&D Digital Solutions Specialist

Experteer Overview

In 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 / Benefits

• Provide 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 permissions
• Support data exports, integrations, issue resolution and user support across clinical studies
• Serve as operational contact for clinical teams to ensure systems enable study delivery
• Coordinate Veeva releases, upgrades and configuration changes with impact assessment and stakeholder communication
• Contribute to evolution of digital solutions, supporting enhancements, automation and data flow improvements
• Support initiatives for data-driven oversight, inspection readiness and operational efficiency
• Provide operational project management support for R&D digital and innovation initiatives
• Execute and maintain CSV activities across the system lifecycle ensuring compliance
• Maintain validated state of GxP systems per GCP, Annex 11 and 21 CFR Part 11; author/execute validation docs with QA
• Support vendor management and coordination with system providers/service partners
• Assist end-user training including material preparation and tracking training completion
• Communicate effectively with technical, quality and business stakeholders

Responsabilità

• 2–5 years of experience supporting digital systems in pharmaceutical or biotech R&D
• Hands-on experience with Veeva Clinical systems (eTMF/CTMS, CDMS, RTSM)
• Practical experience in a GxP-regulated environment with CSV activities
• Solid understanding of GCP, Annex 11 and 21 CFR Part 11 in computerized systems
• Experience supporting clinical studies from systems, data or operational perspectives
• Ability to manage multiple activities/projects simultaneously with high attention to detail
• Experience working in cross-functional, international environments