Clinical Data Standards Architecht

Are you passionate about clinical data standards and looking to make a meaningful impact in the world of clinical research? Join our dedicated global team as a Clinical Data Standards Architect, where you’ll play a key role in streamlining clinical data processes across therapeutic areas. This role is integral to ensuring high-quality data collection and delivery, aligning with industry standards and regulatory requirements.

You will be at the forefront of developing, implementing, and maintaining standard metadata, supporting the full data lifecycle from initial collection to final submission.

You will:

• Implement standard content in data collection and delivery tools, driving consistency, automation, and efficiency across clinical trials.

• Configure standards for specific Therapeutic or Disease Areas to enable optimal reuse and adoption across the R&D portfolio.

• Collaborate with cross-functional teams, including data managers, technical architects, and standards experts, to ensure the correct configuration and adoption of clinical data standards.

• Ensure compliance with industry standards (e.g., CDISC) and health authority regulations, incorporating best practices in computer system validation.

• Conduct testing and quality control of tools, mapping metadata, and standard implementations.

• Maintain and govern master-level data collection and delivery standards, applying formal change control and versioning practices.

• Support lineage and traceability documentation for all pre-configured standards used across studies.

• Provide subject matter expertise to internal teams and external partners (e.g., CROs) on the adoption and implementation of clinical data standards.

Develop and maintain standard CRF mockups, questionnaires, validation rule specifications, and integrations (e.g., IWRS).

Education & Experience:

• Bachelor’s degree in Life Sciences, Computer Sciences, or equivalent experience.

• Minimum of 2 years’ relevant operational experience in clinical data management or data standards.

Technical Skills:

• Strong expertise in Rave eDC (Medidata Solutions).
• Experience with SAS programming; coding skills preferred.
• In-depth understanding of CDISC standards: SDTM, CDASH, define.xml, and Controlled Terminology.
• Familiarity with SAS LSAF and Pinnacle 21 is advantageous.
• Ability to manage multiple priorities effectively in a matrixed environment.

Soft Skills:

• Excellent communication skills, both written and verbal, in English.

• Strong collaboration mindset with the ability to work across global teams and stakeholders.

• High attention to detail and a structured, analytical approach to problem-solving.

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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