Note: The job is a remote job and is open to candidates in USA. ICON plc is a world-leading healthcare intelligence and clinical research organization, and they are seeking a Principal Clinical Data Standards Consultant. This role involves supporting operational staff in the use of ADaM and define.xml for statistical analysis, developing tools for data management, and mentoring other consultants while participating in industry standards initiatives.

Responsibilities

• Serve on Sponsor Standards and Technology Leadership teams
• Consult with clients on sponsor-specific CDISC centric implementation projects
• Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.)
• Author, maintain, implement, and report status for Standards Related Project Plans
• Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards
• Mentor Clinical Data Standards Consultants
• Lead Subject Matter Expert teams on topics relevant to standards
• Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting
• Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards

Skills

• Minimum of 5 years of experience in industry in a role demonstrating knowledge of standards used by biometrics
• An undergraduate degree or international equivalent from an accredited institution
• Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts
• Excellent communication skills with demonstrated leadership ability

Benefits

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Company Overview

Company H1B Sponsorship