At a Glance
- Tasks: Lead the development of clinical data standards and improve processes in a dynamic environment.
- Company: Join ICON plc, a leading healthcare intelligence and clinical research organisation.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and a focus on work-life balance.
- Other info: Inclusive culture with opportunities for mentorship and career growth.
- Why this job: Make a meaningful impact in clinical data standards and contribute to innovative projects.
- Qualifications: 8+ years in clinical data management with expertise in CDISC standards required.
The predicted salary is between 60000 - 80000 € per year.
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Principal Clinical Data Standards Consultant at ICON Plc, you will:
- Provide expert-level functional knowledge in at least one standards domain, contributing to the development of standards content both internally and for sponsor-facing projects.
- Develop, implement, and maintain ICON Data Collection standards libraries in compliance with CDISC, sponsor, and regulatory requirements.
- Act as a subject matter expert to guide standards implementation and ensure compliance across clinical data management activities.
- Apply deep understanding of business challenges to recommend and drive best practices, improving processes, products, and services to enhance competitive differentiation.
- Collaborate cross-functionally to define data collection strategies and standards for clinical trials.
- Participate in standards governance activities, influencing decision-making and providing expert input on complex topics.
- Lead or contribute to departmental initiatives, potentially acting as a project lead with responsibility for coordinating team members.
- Support the development of training materials and reference documentation across standards topics such as CDASH & Controlled Terminology.
- Stay up to date with industry trends, regulatory changes, and emerging standards, ensuring continuous improvement of ICON practices.
- Provide mentorship and guidance to more junior team members.
Requirements:
- A Bachelor’s degree in a relevant discipline (e.g., Life Sciences, Computer Science, or similar); advanced degrees are advantageous.
- Approximately 8+ years of experience in clinical data management, with significant expertise in data standards.
- Advanced proficiency in CDISC standards (CDASH, SDTM, Controlled Terminology, etc.) and strong knowledge of regulatory requirements (FDA, EMA, etc.).
- Proven experience with EDC build/design tools, such as Medidata Rave and/or Veeva Vault EDC/CDMS.
- Demonstrated ability to solve complex problems, using advanced analytical thinking and sound judgment to develop innovative solutions.
- Strong leadership capabilities, including experience leading initiatives or mentoring team members.
- Excellent interpersonal, communication, and influencing skills, with the ability to present, defend analyses, and secure stakeholder alignment on complex topics.
- Ability to significantly impact operational, project, or departmental objectives, ensuring delivery of high-quality outcomes aligned with business strategy.
If you are ready to make a meaningful impact in the field of clinical data standards and contribute to innovative, high-impact clinical projects, we encourage you to apply and join ICON’s growing team.
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.
- 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, 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.
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, color, 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.
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.
Principal Clinical Data Standards Consultant employer: IRE
At ICON plc, we pride ourselves on being a world-leading healthcare intelligence and clinical research organisation that champions innovation and excellence. Our inclusive work culture fosters collaboration and personal growth, offering competitive benefits such as flexible working arrangements, comprehensive health insurance, and a global employee assistance programme. Join us in making a meaningful impact in clinical data standards while enjoying a supportive environment that values your contributions and well-being.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Clinical Data Standards Consultant
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical data field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CDISC standards and regulatory requirements. Be ready to discuss how your experience aligns with ICON's mission and values, showing them you’re not just a fit for the role, but for the company culture too.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your enthusiasm for the position. It keeps you fresh in their minds and shows your professionalism.
✨Tip Number 4
Check out our careers site regularly for new openings. Applying directly through our website can give you an edge, as it shows your genuine interest in joining ICON and helps us keep track of your application more easily.
We think you need these skills to ace Principal Clinical Data Standards Consultant
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Principal Clinical Data Standards Consultant. Highlight your experience with CDISC standards and any relevant projects you've led. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical data standards and how you can contribute to our mission at ICON. Keep it engaging and personal – we love to see your personality come through.
Showcase Your Expertise:In your application, don’t shy away from showcasing your expertise in data management and regulatory requirements. We’re looking for someone who can bring deep knowledge to the table, so let us know how you’ve tackled complex challenges in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at IRE
✨Know Your Standards
Make sure you brush up on your knowledge of CDISC standards, especially CDASH and SDTM. Be prepared to discuss how you've applied these standards in past projects, as this will show your expertise and understanding of regulatory requirements.
✨Showcase Your Leadership Skills
As a Principal Clinical Data Standards Consultant, you'll need strong leadership capabilities. Think of examples where you've led initiatives or mentored team members. Highlighting these experiences will demonstrate your ability to influence and guide others effectively.
✨Prepare for Complex Problem-Solving
Expect questions that assess your analytical thinking and problem-solving skills. Prepare to discuss specific challenges you've faced in clinical data management and the innovative solutions you implemented. This will showcase your ability to tackle complex issues head-on.
✨Engage with Cross-Functional Collaboration
Since collaboration is key in this role, be ready to talk about your experience working with different teams. Share examples of how you've defined data collection strategies and standards in previous roles, as this will highlight your ability to work cross-functionally and drive best practices.
