Senior Clinical Data Standards Architect

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk is seeking a Senior Standards Developer to drive the end-to-end use of clinical data standards across global development projects. You will govern, develop, implement, and continuously improve standards to support compliant and high-quality study execution.

The role involves collaborating with multiple clinical functions to shape standardization and data governance, ensuring accurate metadata capture and downstream availability throughout development lifecycles.

Qualifications

• A relevant educational background within life sciences, clinical information management, pharmacy, nursing, medicine, veterinary science, computer science, or a comparable field.
• Preferably 5+ years of experience in clinical data management, trial management, statistical programming, clinical operations, or another relevant clinical development discipline.
• A good understanding of clinical trial conduct, GxP requirements, and the clinical data flow from data collection through analysis and submission.
• Knowledge of clinical data standards, CRF design, Controlled Terminology, SDTM, and/or metadata-driven clinical systems.
• Strong communication skills, a structured and quality-focused approach, and the ability to collaborate effectively across functions, cultures, and organizational levels.

Responsibilities

• Develop, maintain, and implement clinical data standards across clinical development projects.
• Support governance and operational control of standards, including CRFs and Controlled Terminology.
• Contribute to specification and implementation of end-to-end mapped clinical data standards and related metadata.
• Interpret clinical trial designs to support adoption of data standards.
• Collaborate across Clinical Data Management, Trial Management, Biostatistics, and other functions to drive standardization and compliance.

Skills

Clinical data standards

Cross-functional collaboration

GxP understanding

Regulatory compliance

Communication skills

Education

Bachelor's degree in life sciences or related field

Tools

EDC systems

Metadata repositories

Job description

Novo Nordisk is seeking a Senior Standards Developer to drive the end-to-end use of clinical data standards across global development projects. You will govern, develop, implement, and continuously improve standards to support compliant and high-quality study execution.

The role involves collaborating with multiple clinical functions to shape standardization and data governance, ensuring accurate metadata capture and downstream availability throughout development lifecycles.