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
