Senior Clinical Data Standards Architect

Novo Nordisk A/S; Denmark; Remote; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark invites a Senior Clinical Data Standards Developer to drive end-to-end clinical data standards across development projects. You will govern standards, implement CRFs and terminology, and collaborate with Clinical Data Management, Trial Management, Biostatistics, and more to ensure compliant, high-quality study execution.

You will work with metadata repositories and SDTM knowledge to enable scalable data standards and robust regulatory submissions, contributing

Qualifications

• A relevant educational background in 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 the governance and operational control of standards, including CRFs and Controlled Terminology.
• Contribute to the specification and implementation of end-to-end mapped clinical data standards and related metadata.
• Interpret clinical trial designs and protocols to support the accurate adoption of data standards.
• Collaborate across Clinical Data Management, Trial Management, Biostatistics, Statistical Programming, Clinical Operations, and other relevant functions to drive standardization, compliance, and innovation.

Skills

Clinical data standards

Trial management

Statistical programming

Clinical operations

Data standards governance

Education

Relevant degree in life sciences, clinical information management, pharmacy, nursing, medicine, veterinary science, computer science

Tools

EDC systems

Metadata repositories

SDTM knowledge

Job description

Novo Nordisk A/S in Søborg, Denmark invites a Senior Clinical Data Standards Developer to drive end-to-end clinical data standards across development projects. You will govern standards, implement CRFs and terminology, and collaborate with Clinical Data Management, Trial Management, Biostatistics, and more to ensure compliant, high-quality study execution.

You will work with metadata repositories and SDTM knowledge to enable scalable data standards and robust regulatory submissions, contributing