R&D Digital Solutions Specialist

Job Purpose

The 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 Gx P‑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 (e TMF/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 Gx P 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 Gx P / CSV / Quality Systems is a strong plus.
• Hands‑on experience and/or formal training on Veeva Clinical systems (e. g. Veeva Vault e TMF/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, Clue Points 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 e TMF/CTMS, CDMS and RTSM.
• Practical experience working in Gx P‑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 projects simultaneously, with strong attention to detail.
• Experience working in cross‑functional, international environments.
• Clinical systems knowledge (e TMF/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
• Gx P 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)

At Recordati we believe in people!

Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion.

We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer.

We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

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