Senior Clinical Data Standards Architect

Novo Nordisk A/S

Søborg

On-site

DKK 651,000 - 957,000

Full time

4 days ago

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Job summary

Novo Nordisk in Søborg is seeking a Senior Clinical Data Standards Developer to drive end-to-end standardization of clinical data across development projects. You will shape governance, implementation and continuous improvement of data standards to support compliant study execution.

Collaborating with Clinical Data Management, Trial Management, Biostatistics and IT, you will define CRFs, Controlled Terminology and metadata specifications, ensuring accurate adoption of data standards throughout

Qualifications

Educational background in life sciences, clinical information management, pharmacy, nursing, medicine, veterinary science, computer science.
Preferably 5+ years of experience in clinical data management or related clinical development.
Solid understanding of GxP and clinical data flow from collection to submission.
Knowledge of SDTM, CRF design and Controlled Terminology.
Strong cross-functional collaboration and communication skills.

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 end-to-end mapped clinical data standards and metadata.
Interpret trial designs to support adoption of data standards.
Collaborate across functions to drive standardization, compliance, and innovation.