Senior Data Standards Expert (all genders)

Overview

In this role you shape and maintain clinical data standards and design high-quality electronic case report forms for global studies. You lead complex study builds in eDC systems and ensure alignment with CDISC standards. You oversee external partners' deliverables, support submission readiness, and advance governance and automation in data standards. You will mentor colleagues and collaborate across clinical data management, programming, regulatory, and technology teams. This is a hands-on, globally impactful position with a flexible, inclusive culture.

Pay / Benefits

• inclusion and belonging culture
• personal development and career advancement
• global opportunities
• flexible working culture
• diverse backgrounds valued
• opportunity to impact patient outcomes

Responsibilities

• Shape and maintain clinical data standards
• Design high-quality electronic case report forms (CRFs) for global studies
• Lead complex study builds in electronic data capture systems (eDC)
• Manage metadata and standards libraries
• Ensure alignment with CDISC, CDASH and SDTM requirements
• Oversee standards deliverables from external partners
• Support submission readiness and manage study-level standards exceptions
• Apply quality-by-design principles and drive governance improvements
• Mentor colleagues and promote automation and new data formats

Key requirements

• Advanced degree in life sciences, computer science or equivalent experience
• 6-8 years in clinical data standards, data management or eDC design
• Strong CDISC, CDASH, SDTM, metadata and CRF design expertise
• Experience leading complex studies and cross-functional projects
• Knowledge of regulatory submissions and validation tools
• Clear communication, problem-solving and mentoring skills
• On-site in Feltham, UK for 3 days per week

• Clear communication
• Problem-solving
• Mentoring
• CDISC
• CDASH
• SDTM

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