Clinical Data Standards Architecht
Clinical Data Standards Architecht

Clinical Data Standards Architecht

Full-Time 36000 - 60000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Join us as a Clinical Data Standards Architect, streamlining clinical data processes and ensuring high-quality data delivery.
  • Company: ICON is a global leader in clinical research, dedicated to improving patient outcomes through innovative solutions.
  • Benefits: Enjoy competitive salary, flexible benefits, health insurance, and a supportive work-life balance.
  • Why this job: Make a meaningful impact in clinical research while collaborating with diverse teams and enhancing your skills.
  • Qualifications: Bachelor’s degree in Life Sciences or Computer Sciences; 2 years’ experience in clinical data management required.
  • Other info: We value diversity and inclusion, encouraging all qualified applicants to apply regardless of background.

The predicted salary is between 36000 - 60000 £ per year.

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.

#LI-JF1 #J-18808-Ljbffr

Clinical Data Standards Architecht employer: ICON Strategic Solutions

At ICON, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of clinical research. Our commitment to employee growth is reflected in our comprehensive benefits package, which includes competitive salaries, flexible working arrangements, and a focus on well-being for you and your family. Join us in a supportive environment where your expertise as a Clinical Data Standards Architect will not only be valued but will also contribute to meaningful advancements in healthcare.
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Contact Detail:

ICON Strategic Solutions Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Clinical Data Standards Architecht

✨Tip Number 1

Familiarise yourself with CDISC standards, especially SDTM and CDASH, as these are crucial for the role. Consider joining online forums or groups focused on clinical data standards to stay updated and network with professionals in the field.

✨Tip Number 2

Gain hands-on experience with Rave eDC and SAS programming if you haven't already. You could work on personal projects or volunteer for organisations that need help with data management to build your skills and showcase your expertise.

✨Tip Number 3

Highlight your collaboration skills by seeking opportunities to work on cross-functional teams, even in a volunteer capacity. This will demonstrate your ability to work effectively with diverse groups, which is essential for this role.

✨Tip Number 4

Prepare to discuss specific examples of how you've implemented or maintained data standards in previous roles. Being able to articulate your experience with real-world applications will set you apart during interviews.

We think you need these skills to ace Clinical Data Standards Architecht

Clinical Data Management
CDISC Standards Knowledge (SDTM, CDASH, define.xml)
Rave eDC Expertise
SAS Programming Skills
Metadata Configuration
Quality Control and Testing
Change Control and Versioning Practices
Data Lifecycle Management
Collaboration with Cross-Functional Teams
Attention to Detail
Analytical Problem-Solving
Communication Skills (Written and Verbal)
Project Management in a Matrixed Environment
Subject Matter Expertise in Clinical Data Standards
Familiarity with SAS LSAF and Pinnacle 21

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Clinical Data Standards Architect position. Familiarise yourself with clinical data standards, CDISC guidelines, and the specific tools mentioned in the job description.

Tailor Your CV: Customise your CV to highlight relevant experience in clinical data management and your expertise in Rave eDC and SAS programming. Emphasise any previous roles where you implemented or maintained data standards, as well as your collaboration with cross-functional teams.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your understanding of the importance of data standards. Use specific examples from your past experience to demonstrate how you can contribute to the role and the company.

Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is clear, concise, and professional, reflecting your attention to detail, which is crucial for this role.

How to prepare for a job interview at ICON Strategic Solutions

✨Showcase Your Technical Expertise

Be prepared to discuss your experience with Rave eDC and SAS programming. Highlight specific projects where you implemented CDISC standards, as this will demonstrate your technical proficiency and relevance to the role.

✨Understand the Clinical Data Lifecycle

Familiarise yourself with the full data lifecycle from collection to submission. Be ready to explain how you have contributed to streamlining processes in previous roles, as this aligns closely with the responsibilities of a Clinical Data Standards Architect.

✨Emphasise Collaboration Skills

Since the role involves working with cross-functional teams, prepare examples that showcase your ability to collaborate effectively. Discuss how you’ve worked with data managers, technical architects, or external partners to achieve common goals.

✨Prepare for Compliance Questions

Expect questions about compliance with industry standards and regulations. Brush up on your knowledge of CDISC and health authority regulations, and be ready to discuss how you ensure adherence to these standards in your work.

Clinical Data Standards Architecht
ICON Strategic Solutions

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