Principal Clinical Data Standards Consultant

What you will be doing

• 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, TermiNlogy, 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 ICONs practices.

Your profile

• A Bachelors 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 biotechNlogy 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.

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, 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.