Senior Clinical Data Standards Architect

Biopharma Careers; Søborg; 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 development projects. You will contribute to governance, development, implementation, and continuous improvement of standards, enabling compliant and high-quality study execution across the organization.

You will collaborate with Clinical Data Management, Trial Management, Biostatistics, and other functions to ensure standards are captured in metadata repositories and downstream

Qualifications

• Relevant educational background in life sciences, clinical information management, pharmacy, medicine, or related field.
• 5+ years of experience in clinical data management, trial management, statistical programming, or clinical operations.
• Good understanding of GxP and the data flow from collection to submission.
• Knowledge of CRF design, Controlled Terminology, SDTM, and metadata-driven systems.
• Strong communication and collaboration across functions, cultures, and levels.
• Experience with metadata repositories or ED C systems is a plus.

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 the specification and implementation of end-to-end mapped clinical data standards and related metadata.
• Interpret clinical trial designs and protocols to support accurate adoption of data standards.
• Collaborate across Clinical Data Management, Trial Management, Biostatistics, Statistical Programming, Clinical Operations, and other functions to drive standardization and compliance.
• Work with clinical metadata in relevant systems and repositories to ensure standards are captured and available downstream.

Skills

Clinical data management

GxP knowledge

SDTM

Cross-functional collaboration

Communication skills

Metadata systems

Education

Life sciences or related field

Job description

Novo Nordisk is seeking a Senior Standards Developer to drive the end-to-end use of clinical data standards across development projects. You will contribute to governance, development, implementation, and continuous improvement of standards, enabling compliant and high-quality study execution across the organization.

You will collaborate with Clinical Data Management, Trial Management, Biostatistics, and other functions to ensure standards are captured in metadata repositories and downstream