Principal Clinical Data Standards Consultant

Job title: Principal Clinical Data Standards Consultant

About the Role As a Principal Clinical Data Standards Consultant at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You'll Do

• Coordinating consulting and advisory services delivery, resolving issues, and developing team capability.
• Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
• Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
• Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements.
• Managing the development and maintenance of data management processes and tools.
• Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

What We're Looking For

• Bachelor's degree in life sciences, computer science, or a related discipline
• Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry
• Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).
• Excellent analytical and problem-solving skills with a keen attention to detail
• Excellent communication and collaboration abilities to work effectively in cross-functional teams
• Willingness to travel as required (approximately 15%)

Nice to Have

Compensation & Benefits

• Competitive salary
• Various annual leave entitlements
• Health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme LifeWorks (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
• Visit our careers site to read more about the benefits ICON offers.