Clinical AI Validation & Compliance Specialist

Cph Ai Hub; Aalborg; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk seeks a Validation & Compliance Specialist in Denmark to drive validation of clinical data science processes using AI, ensuring fit-for-use before study data touch it. You will help build AI validation expertise in GCP-regulated environments and support responsible AI in clinical research.

You will collaborate with QA, data scientists, IT and external partners to assess risks, prepare validation plans and manage deviation handling, change control and documentation, with emphasis on

Qualifications

• A degree in information technology, computer science, engineering, data science or related discipline.
• Extensive experience in validation and compliance in pharma/biotech/medical devices or clinical research.
• Strong understanding of risk-based validation, data integrity and change control.
• Ability to evaluate how systems and supplier services support controlled workflows.
• Interest in AI validation with motivation to develop expertise.
• Excellent written and spoken English; strong communication skills.

Responsibilities

• Drive validation planning and coordination for new or updated clinical data science processes.
• Assess and document process risks with the Project Clinical Data Scientist.
• Prepare and maintain Process Validation Plans and Reports and secure approvals.
• Run risk-based walkthroughs, perform reviews, document findings and coordinate corrective actions.
• Assess changes and incidents for impact and determine needed validation.
• Support AI System Responsible in defining context of use, model risk and evaluation criteria.
• Coach colleagues and improve validation templates, procedures, and training.

Skills

Validation experience

Regulatory knowledge

Risk assessment

Documentation skills

Stakeholder management

English proficiency

Education

IT/CS/Engineering degree

Tools

Python

R

Quality Management System

Job description

Novo Nordisk seeks a Validation & Compliance Specialist in Denmark to drive validation of clinical data science processes using AI, ensuring fit-for-use before study data touch it. You will help build AI validation expertise in GCP-regulated environments and support responsible AI in clinical research.

You will collaborate with QA, data scientists, IT and external partners to assess risks, prepare validation plans and manage deviation handling, change control and documentation, with emphasis on