Senior Clinical Data Standards Consultant

ICON plc continues to drive efficiencies through the standardization of data management practices. This role supports the creation and maintenance of content in the Data Standards Catalog under guided supervision. The individual will collaborate with representatives from various functions and leverage industry standards to develop clinical data collection instruments and their associated checks.

• Update metadata definitions and specifications in line with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology.

• Participate in relevant governance team meetings and provide input on standards as assigned.

• Collaborate with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy, ensuring compliance with regulations and internal governance procedures.

• May act as a subject matter expert (SME) for specific topics.

• Provide ongoing support to the Data Management organization and key stakeholders (e.g., Clinical, Biostatistics, Medical, Medical Writing, etc.).

• Contribute to Data Management or cross-functional initiatives as needed.

• May oversee and hold accountable CRO/FSP data managers and/or database development teams.

• Attend and represent the Data Standards team in the following forums, including but not limited to:

  • Data Standards Governance meetings

  • Clinical study team meetings

  • Project update meetings

You are:

• Demonstrates a foundational knowledge of Data Management and Data Standards processes, along with awareness of industry best practices.

• Basic understanding of applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.

• CDISC standards, SCDM certification, or Medidata RAVE certification is a plus.

• Minimum of 2 years of clinical data standards experience in biotechnology, pharmaceutical, or health related
  industry is required.
• Education: Requires BS in a Science, Health or Computing, or related field

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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.