Clinical AI Validation & Compliance Specialist

Novo Nordisk A/S; Søborg, Aalborg; Remote; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk is seeking a qualified professional to validate clinical data science processes, ensuring they are fit for use with clear, auditable evidence. You will drive validation planning, assess risks with the Project Clinical Data Scientist, and secure approvals prior to production use.

The role includes collaboration with QA, data scientists, software developers, and external partners. You will contribute to AI validation, model risk assessment and human oversight, and help evolve

Qualifications

• Must have strong validation and compliance background.
• Experience leading validation activities in pharma/biotech/clinical research.
• Ability to translate complex technical information into validation documentation.

Responsibilities

• Drive validation planning for clinical data science processes from data ingestion through analysis and finalisation.
• Assess process risks with Project Clinical Data Scientist and link requirements to controls.
• Prepare and maintain Process Validation Plans and Reports and secure approvals before production use.
• Perform risk-based walkthroughs, spot checks, and post-use validation reviews.
• Support AI System Responsible and AI specialists in defining context of use, model risk and human oversight.
• Coach colleagues and improve validation templates, procedures and training.

Skills

Validation

Compliance

Risk-based validation

Data integrity

Documentation

AI validation

English communication

Education

Degree in IT/CS/Engineering/Data Science/Life Sciences

Tools

Python

R

Job description

Novo Nordisk is seeking a qualified professional to validate clinical data science processes, ensuring they are fit for use with clear, auditable evidence. You will drive validation planning, assess risks with the Project Clinical Data Scientist, and secure approvals prior to production use.

The role includes collaboration with QA, data scientists, software developers, and external partners. You will contribute to AI validation, model risk assessment and human oversight, and help evolve