IRT Manager

Role Summary

IRT Manager is responsible for leading IRT management within Global Clinical Drug Supply, Technical Operations to ensure timely and high-quality clinical trial supplies for early- and late-stage studies. The role is based in Copenhagen with onsite presence 3 days/week.

Responsibilities

• IRT Portfolio & Project Management: Oversee the full lifecycle of trial-specific IRT systems (setup, maintenance, decommissioning); coordinate implementation, requirements, UAT planning/execution, integrations, documentation, and training; ensure adherence to IRT standards and proactively manage risks; manage multiple projects with cross-functional stakeholders; communicate project status and participate in operational planning.
• IRT Vendor Management: Support KPIs, metrics, and trend analysis to anticipate and mitigate risks; oversee vendor activities ensuring quality and compliance; collaborate with vendor project managers for assigned trials and support audits/inspection readiness; facilitate problem resolution and corrective actions.
• Continuous Improvement: Provide inputs for process improvements; support cross-functional training and initiatives; assist in creation/maintenance of SOPs, work instructions, and job aids.

Qualifications

• Bachelor’s degree in a scientific or technical field; advanced degree/certification preferred
• 2+ years’ experience in supply chain or related areas within pharma, biotech, or medical devices
• Strong knowledge of regulatory standards (GMP, GCP, ICH)
• Hands-on experience with IRT systems preferred
• Proven ability to manage large projects with multiple stakeholders
• Experience working in cross-functional, multicultural teams