Sr Clinical Systems Designer (Veeva Library)

ICON; Chennai; On-site; INR 1,800,000 - 3,000,000; Full time

Benefits offered by this job

Health insurance

Global opportunities

Competitive salary

Flexible leave policy

Job summary

ICON Strategic Solutions seeks a Senior Clinical Systems Designer (Veeva Library) to design and implement advanced clinical systems that enhance trial design and execution. You will create reusable eCRFs and manage library components within Veeva EDC, aligning with data standards and protocol requirements.

The role involves developing specifications, validation, UAT, and cross-functional collaboration with Data Management, IT, and CROs to ensure inspection readiness and TMF documentation.

Qualifications

• 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.

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.

Skills

Veeva EDC

eCRF design

Data Management

Stakeholder management

GxP knowledge

JSON/C# basics

Education

Bachelor's degree or equivalent

Tools

CQL

CDB

JSON

C#

Job description

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.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here