Senior Clinical Data Standards Consultant

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned will be essential. Collaborating with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy, ensuring compliance with regulations and internal governance procedures will be part of your responsibilities. As a subject matter expert (SME) for specific topics, you may provide ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing departments. Additionally, you will contribute to Data Management or cross-functional initiatives as needed and oversee CRO/FSP data managers and/or database development teams. You will represent the Data Standards team in various forums, including Data Standards Governance meetings, Clinical study team meetings, and Project update meetings. Demonstrating a foundational knowledge of Data Management and Data Standards processes, along with an awareness of industry best practices, is key to excelling in this role. Having a basic understanding of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection is required. An ideal candidate would have a minimum of 2 years of clinical data standards experience in the biotechnology, pharmaceutical, or health-related industry. Possessing CDISC standards, SCDM certification, or Medidata RAVE certification is considered a plus. The role requires a Bachelor's degree in a Science, Health, Computing, or related field. At ICON, we value our employees and offer a competitive salary along with a range of benefits designed to promote well-being and work-life balance. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, discounted gym memberships, and health assessments. To learn more about the benefits of working at ICON, visit our careers website at https://careers.iconplc.com/benefits. If you are interested in the role but unsure if you meet all the requirements, we encourage you to apply as you may be exactly what we are looking for at ICON, whether for this position or other roles.,