Senior Clinical Data Standards Consultant

Overview 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 Responsibilities 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 Qualifications 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 color religion sex sexual orientation gender identity national origin disability or protected veteran status 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