Senior Principal Clinical Data Standards Consultant

Senior Principal Clinical Data Standards Consultant - UK, Reading

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.

We are currently seeking a Senior Principal Clinical Data Standards Consultant to join our diverse and dynamic team. The Senior Principal Clinical Data Standards Consultant will develop and implement ICON data standards libraries for data collection and SDTM. They will provide internal and external consulting services on topics related to CDISC standards compliance and standards implementation. They will support sponsors on the development, implementation, maintenance, and governance of data standards content.

Develop and deliver training for both internal teams and for external sponsors on CDISC standards related topics
Support the development and maintenance of technologies used for the implementation of data standards
Provide sponsors with expert reviews of regulatory submission data packages for compliance with required data standards and submission readiness
Lead standards governance team meetings and provide standards input as necessary
May perform expert reviews of study artifacts (i.e. eCRFs, programming specifications, datasets and define.xml files etc.)
Participate in the recruitment, interviewing, and mentoring of new team members
Support business development in securing new business
Lead subject-level SME teams
Medium to large portfolio oversight of functional project teams and or projects of a complex nature.
Contribute to development of initiatives for the department, possibly as project lead being responsible for other team members in a team lead role, but not as a line manager
Lead others to solve complex problems while using sophisticated analytical thought to exercise judgement and identify innovative solutions
Significantly impact the achievement of operational, project, or department objectives and ensures quality standards are achieved
Travel (approximately 5%) domestic and/or international

15+ years of related experience in data collections standards in the clinical research industry
Advanced knowledge of SDTM standards and of regulatory submission requirements pertaining to tabulation data
Ability to apply expert knowledge of business challenges, and recommend best practices to improve products, processes or services to differentiate the business market
Bachelor’s degree

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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 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