Technical System Manager (Clinical Operations, Hellerup)

Job summary

The role involves managing technical systems for clinical operations and clinical trial supply, focusing on IRT, CTMS, and eTMF solutions. The Technical System Manager will ensure system stability, functionality, and compliance with inspection readiness.

Qualifications

• Relevant academic degree, preferably a Master’s, in Engineering, System Management, or a related technical field.
• Minimum of 5 years of experience with clinical systems in a pharmaceutical context.
• Strong understanding of Clinical Operations and Clinical Trial Supply processes and systems.
• Experience working with SaaS vendors and GxP processes for system management.

Responsibilities

• Serve as the technical expert for eTMF, CTMS, and IRT solutions.
• Translate business requirements into system configuration specifications.
• Implement configurations directly or coordinate with vendors.
• Ensure systems are validated and inspection-ready.
• Prepare documentation for audits and inspections.
• Oversee system support and manage escalation of issues.
• Maintain oversight of vendor operations.
• Facilitate end-user training and user group sessions.
• Propose and implement improvements for automation and data flow.
• Collaborate with IT product teams to solve problems and deliver solutions.

Skills

• Strong analytical skills and a proactive, can-do attitude.
• Ability to collaborate effectively in complex and ambiguous environments.
• Strong team player with an entrepreneurial mindset.

Education

• Master’s degree preferred, with a background in Engineering, System Management, or a related technical field.

Tools

• Experience with SaaS applications, eTMF, CTMS, and IRT systems.