Principal Clinical Data Standards Specialist

Lead and shape clinical data standards strategy within a global clinical research setting. You will guide the design and maintenance of standards libraries, ensure regulatory alignment, and advise cross-functional teams on data collection frameworks. Your work supports governance, capability development, and adoption of best practices in data standards across studies. This role offers impact on oncology programs and collaboration with diverse stakeholders.

• Serve as a subject matter expert in clinical data standards and related processes
• Design, develop, and maintain standards libraries and documentation for clinical data collection
• Ensure standards align with industry norms, organizational requirements, and regulatory expectations
• Provide strategic guidance on standards implementation across studies and programmes
• Partner with stakeholders to establish data collection approaches and standards frameworks
• Evaluate operational challenges and propose standards-based solutions
• Contribute to tool, methodology, and practice enhancements
• Support governance activities with expert recommendations on complex topics
• Lead and participate in cross-functional projects and business improvement efforts
• Coordinate contributors and stakeholders for standards-focused activities
• Produce and maintain training resources and reference materials on data standards and terminology
• Monitor evolving regulations and industry developments to ensure compliance and best practices
• Provide mentoring and technical support to colleagues across the function
• Communicate recommendations effectively and build consensus among diverse groups

• Bachelor's degree in Life Sciences, Computer Science, Information Management, or related discipline
• Significant experience in clinical data standards, clinical data management, or related functions within pharmaceutical, biotechnology, or clinical research sectors
• Strong knowledge of CDASH, SDTM, controlled terminology, and submission requirements
• Understanding of global regulatory expectations and data standards frameworks
• Experience using electronic data capture (EDC) systems and other clinical technology platforms
• Proven ability to investigate and resolve complex data standards challenges
• Experience leading projects, workstreams, or process improvement initiatives
• Strong communication, presentation, and stakeholder engagement skills
• Ability to influence decision-making through data-driven recommendations and expert insight
• Proven track record of delivering high-quality outputs in a regulated environment

• strong communication
• stakeholder engagement
• influence and consensus-building
• CDASH
• SDTM
• controlled terminology