Global Clinical Trial Supply Lead (GMP/GDP)

Ascendis Pharma; Gentofte Kommune; On-site; DKK 900,000 - 1,150,000; Full time

Job summary

Ascendis Pharma seeks a Clinical Trial Supply Manager to lead CTS activities for Phase 1–3 studies. Based in Hellerup, Denmark, you will coordinate with CMC, Trial Management, QA, IT, and Regulatory Affairs to forecast and plan IMP supply, manage IRT setup and distribution with CMOs and sites.

Fluent in English and Danish, with a pharmacy-related degree and at least 5 years in CTS or GMP/GDP environments. Global collaboration and travel up to 10 days/year are involved.

Qualifications

• Academic degree in pharmacy or related field.
• 5+ years in CTS or GMP/GDP-regulated environment.
• Experience managing complex projects with internal and external stakeholders.

Responsibilities

• Coordinate internal CTS trial meetings and activities with internal departments (CMC, Trial Management, QA, IT, Regulatory).
• Forecast, plan and facilitate IMP supply, including packaging design and labeling.
• Manage IRT setup, including specification, UAT, Go-live and post Go-live changes.
• Oversee IMP distribution from CMOs to sites, including DtP shipments and temperature excursion management.
• Manage drug accountability activities, including returns, reconciliation and destruction.
• Participate in meetings with CMOs, suppliers and trial teams.
• Maintain QMS and eTMF documentation, and prepare trial-related instructions and manuals.

Skills

Stakeholder management

Regulatory knowledge

MS Office

English & Danish

Education

Pharmacy degree or related field

Job description

Ascendis Pharma seeks a Clinical Trial Supply Manager to lead CTS activities for Phase 1–3 studies. Based in Hellerup, Denmark, you will coordinate with CMC, Trial Management, QA, IT, and Regulatory Affairs to forecast and plan IMP supply, manage IRT setup and distribution with CMOs and sites.

Fluent in English and Danish, with a pharmacy-related degree and at least 5 years in CTS or GMP/GDP environments. Global collaboration and travel up to 10 days/year are involved.