Prinicipal Clinical Data Standards Consultant

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Principal Clinical Data Standards Consultant at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

Your focus will be on coordinating consulting and advisory services delivery, resolving issues, and developing team capability.

Key responsibilities include:

As a Senior Clinical Data Standards Consultant at ICON Plc, you will be responsible for:
Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements.
Managing the development and maintenance of data management processes and tools.
Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

Your Profile:

You will have solid consulting and advisory services experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

To excel in this role, you should possess the following qualifications and attributes:
Bachelor's degree in life sciences, computer science, or a related discipline
SDTM expert with a background that includes programming in SAS, R and other languages.
Should have a minimum of 8 years experience in the industry in roles that demonstrate the knowledge and skill in the above.
Statistical programming role focused on SDTM tasks.
Should demonstrate leadership skills
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 a keen attention to detail.
Excellent communication and collaboration abilities to work effectively in cross-functional teams.
Willingness to travel as required (approximately 15%)

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

Principal Clinical Data Standards Consultant

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