Principal Clinical Data Standards Consultant

Principal Clinical Data Standards Consultant _ Remote

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.

Are you an expert with practical experience in CDISC and CDASH standards?

Do you have build/design experience in Medidata Rave EDC and/or Veeva Clinical Data (Vault CDMS/EDC)?

If so, join our diverse and dynamic team at ICON as a Principal Clinical Data Standards Consultant! As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in the development and implementation of forms for the ICON Standards team internally and for our esteemed sponsors.

Job Summary

As a Principal Clinical Data Standards Consultant at ICON Plc, you will be responsible for:

• Developing and implementing ICON's standards libraries in compliance with CDISC, Sponsor, and ICON standards.

• Managing the development and maintenance of data management processes and tools.

• Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.

• Participating in standards governance team meetings and offering standards input as required.

• Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Controlled Terminology, ADaM, define-XML and regulatory submission requirements.

• Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

Requirements

To excel in this role, you should possess the following qualifications and attributes:

• A Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus.

• Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.

• Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).

• Excellent analytical and problem-solving skills with keen attention to detail.

• Excellent interpersonal skills, communication and collaboration abilities to work effectively in cross-functional teams.

• Strong problem-solving abilities and the capacity to impact operational and departmental objectives significantly.
   

If you are ready to make a substantial impact in the field of CDASH standards and contribute to cutting-edge projects at ICON, apply now to join our dynamic 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.

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, subsidized 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, 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.

Are you a current ICON Employee? Please click here to apply