Senior Clinical Systems Designer - Veeva Library

Senior Clinical Systems Designer (Veeva Library)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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

What You Will Do:

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.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply