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- 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 work-life balance, health insurance, and various perks like gym memberships and childcare vouchers.
- Why this job: Make a meaningful impact in clinical research while collaborating with diverse teams and developing industry standards.
- 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, offering equal opportunities for all applicants.
The predicted salary is between 43200 - 72000 £ 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.
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Clinical Data Standards Architecht employer: ICON plc
Contact Detail:
ICON plc 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 allow you to apply these skills practically, which will make you stand out.
✨Tip Number 3
Showcase your collaboration skills by participating in cross-functional team projects, even in a volunteer capacity. Highlighting your ability to work effectively with diverse teams can be a significant advantage during interviews.
✨Tip Number 4
Prepare for potential interviews by practising common questions related to clinical data management and standards. Be ready to discuss specific examples of how you've implemented or maintained data standards in previous roles.
We think you need these skills to ace Clinical Data Standards Architecht
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical data management and data standards. Emphasise your expertise in CDISC standards and any specific tools mentioned in the job description, such as Rave eDC.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical data standards and your understanding of their importance in clinical research. Mention specific examples of how you've contributed to data quality and compliance in previous roles.
Highlight Technical Skills: Clearly outline your technical skills related to SAS programming and any familiarity with tools like Pinnacle 21. This will demonstrate your capability to handle the technical aspects of the role effectively.
Showcase Soft Skills: In your application, provide examples of your communication and collaboration skills. Highlight experiences where you worked with cross-functional teams, as this is crucial for the role.
How to prepare for a job interview at ICON plc
✨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.
✨Emphasise Collaboration Skills
Since the role involves working with cross-functional teams, share examples of how you've successfully collaborated with data managers, technical architects, or other stakeholders in previous roles. This will show your ability to work effectively in a team environment.
✨Demonstrate Attention to Detail
Prepare to discuss how you ensure high-quality data collection and delivery. Provide examples of how you've conducted testing and quality control in past projects, showcasing your structured and analytical approach to problem-solving.
✨Understand the Company Culture
Familiarise yourself with ICON's commitment to inclusion and belonging. Be ready to discuss how you can contribute to a diverse culture and how your values align with theirs, which will help you stand out as a candidate who fits well within their team.
