Sr Clinical Systems Designer (Veeva Library)

Location: India, Chennai

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
• Additional Locations: India, Trivandrum, India, Bangalore