Job Description & How to Apply Below
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. 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.
• Demonstrated ability to manage multiple activities and…
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