Senior Clinical Systems Designer (Veeva Library)

As a Senior Clinical System Designer at ICON, you will design and implement advanced clinical systems that enhance trial design and execution.

Key Responsibilities:

• Design, develop, validate, and maintain reusable eCRFs and library components within Veeva EDC.
• Create and maintain eCRF specifications, edit-check specifications, dynamics, and derivations.
• Establish library collections, version control, change management, and governance processes.
• Ensure library components align with clinical data standards and protocol requirements.
• Optimize library design to balance reusability, study needs, and ongoing maintenance.
• Support lab modules and integrations with IRT, safety, coding, local laboratories, and other clinical systems.
• Develop and execute UAT scripts and validate EDC configurations.
• Understand how library components are consumed and implemented at the study level.
• Troubleshoot database and library-configuration issues and implement post-production changes.
• Understand backend EDC data, raw/CDM outputs, SDTM structures, and downstream data-model requirements.
• Partner with Data Management, Standards, Clinical Operations, Clinical Supplies, IT, Quality, CROs, and technology vendors.
• Support EDC standards, governance models, inspection readiness, and TMF documentation.
• Identify opportunities to automate and streamline the specification-to-build process.
• Track deliverables, milestones, risks, and quality metrics.

Required Skills and Experience:

• Bachelor’s degree or equivalent relevant experience.
• 6+ years of experience in Data Management, EDC programming, Clinical IT, or related clinical-research functions.
• 3–5 years of hands-on Veeva Library development and maintenance experience.
• Strong hands-on experience with Veeva EDC is mandatory.
• Experience in eCRF design, EDC programming, edit checks, dynamics, derivations, and lab modules.
• Knowledge of clinical data standards and protocol interpretation.
• Experience with reusable components, library collections, version control, and governance.
• Understanding of blinded and unblinded study configurations.
• Experience integrating EDC with laboratories, safety systems, IRT, coding, and other clinical-trial modules.
• Understanding of raw/CDASH, SDTM structures, and downstream data consumption.
• Experience with CQL, CDB, JSON, or C# is preferred but not mandatory.
• Understanding of CTMS, SAS, R, Python, data warehouses, or SharePoint is advantageous.

Other Requirements:

• Independent lead contributor who can translate broad requirements into workable solutions.
• Ability to think beyond provided specifications, challenge assumptions, and recommend improvements.
• Strong problem-solving, stakeholder-management, and cross-functional collaboration skills.
• Ability to deliver confidently with limited supervision and reduced review cycles.

Rewards & Benefits:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways