Clinical Systems Lead for eTMF, CTMS & IRT

Ascendis Pharma; Hellerup; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ascendis Pharma in Denmark is seeking a Technical System Manager to align clinical operations and trial supply systems (eTMF, CTMS, IRT) with our SaaS-based landscape. You will translate business needs into technical configurations, ensure validation and inspection readiness, and support audits.

You will report to the Global Head of Digitalization and work from Hellerup, Denmark. Travel up to 10–15 days per year is expected for cross-site collaboration and audits.

Qualifications

• Master's degree in engineering or a related technical field.
• 5+ years of experience with clinical systems in pharma.
• Experience with SaaS vendor management and GxP processes.

Responsibilities

• Be the technical expert for eTMF, CTMS and IRT solutions.
• Translate business needs into configuration specs for SaaS applications.
• Implement configurations yourself or coordinate with providers/vendors.
• Ensure systems are validated and inspection-ready.
• Prepare and present systems documentation during audits/inspections.
• Oversee system support and act as escalation point for tickets.
• Maintain operational oversight over vendors.
• Facilitate end-user training and user groups.
• Suggest and implement improvements for automation, integration and data flows.

Skills

Strong teamwork

Analytical mindset

Entrepreneurial mindset

Education

Master’s degree in Engineering or technical field

Tools

eTMF

CTMS

IRT

Job description

Ascendis Pharma in Denmark is seeking a Technical System Manager to align clinical operations and trial supply systems (eTMF, CTMS, IRT) with our SaaS-based landscape. You will translate business needs into technical configurations, ensure validation and inspection readiness, and support audits.

You will report to the Global Head of Digitalization and work from Hellerup, Denmark. Travel up to 10–15 days per year is expected for cross-site collaboration and audits.