Clinical Trial Supply Lead – IRT, DtP & GMP/GDP

Ascendis Pharma; Denmark; On-site; DKK 700,000 - 900,000; Full time

Job summary

Ascendis Pharma seeks a Clinical Trial Supply Manager to oversee parts of the CTS chain for Phase 1–3 trials. Based in Hellerup, Denmark, you will collaborate with cross-functional global teams to plan, coordinate, and optimize IMP supply, packaging, and distribution. Fluency in English and Danish is required.

You will manage IRT setup, packaging runs, and regulatory compliance while maintaining QMS/eTMF documentation and coordinating with CMOs and trial teams. Travel 2–10 days/year.

Qualifications

• Ideally, you hold a relevant academic degree in pharmacy or a related field and have at least 5 years of relevant experience in clinical trial supply management or a GMP/GDP-regulated environment.
• Proven experience in managing complex projects involving multiple internal and external stakeholders
• A strong understanding of regulatory requirements
• Proficiency in Microsoft Office
• Fluency in written and spoken English and Danish

Responsibilities

• Coordinating internal CTS trial meetings and activities and collaborating with internal departments incl. CMC, Trial Management, QA, IT, and Regulatory Affairs
• Forecasting, planning, and facilitating the supply of IMP for clinical trial supplies, including managing IMP Packaging and Labelling activities, packaging design, label text development, and planning of packaging runs
• Managing IRT setup, incl. IRT specification, UAT preparation and execution, Go-live and close-out, as well as managing IRT system changes after Go-live
• Managing IMP distribution from CMOs to clinical sites incl. direct-to-patient (DtP) shipments and management of temperature excursions during storage at depots and clinical sites and during shipments
• Managing drug accountability activities, including returns, reconciliation and destruction
• Participating in meetings with CMOs, suppliers and vendors, trial teams and Investigator Meetings
• Maintaining documentation in the QMS and eTMF, including reviewing and preparing trial-related instructions and manuals

Skills

MS Office

English proficiency

Danish proficiency

Stakeholder management

Education

Pharmacy degree or related field

Tools

Microsoft Office

Job description

Ascendis Pharma seeks a Clinical Trial Supply Manager to oversee parts of the CTS chain for Phase 1–3 trials. Based in Hellerup, Denmark, you will collaborate with cross-functional global teams to plan, coordinate, and optimize IMP supply, packaging, and distribution. Fluency in English and Danish is required.

You will manage IRT setup, packaging runs, and regulatory compliance while maintaining QMS/eTMF documentation and coordinating with CMOs and trial teams. Travel 2–10 days/year.