Clinical Trial Supply Lead – GMP/GDP (CTS)

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

Job summary

Ascendis Pharma is hiring a Clinical Trial Supply Manager to lead CTS activities across Phase 1-3 in a GMP/GDP-regulated setting. The role is based in Hellerup, Denmark, with collaboration across CMC, Trial Management, QA, IT, and Regulatory Affairs.

You will forecast supply of IMP, manage IRT setup and distribution from CMOs to sites, and ensure regulatory compliance while maintaining QMS/eTMF documentation. Travel is modest; English and Danish fluency is expected.

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
• 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 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

GMP/GDP compliance

Project management

Microsoft Office

Biopharma domain

Education

Bachelor's degree in Pharmacy

Job description

Ascendis Pharma is hiring a Clinical Trial Supply Manager to lead CTS activities across Phase 1-3 in a GMP/GDP-regulated setting. The role is based in Hellerup, Denmark, with collaboration across CMC, Trial Management, QA, IT, and Regulatory Affairs.

You will forecast supply of IMP, manage IRT setup and distribution from CMOs to sites, and ensure regulatory compliance while maintaining QMS/eTMF documentation. Travel is modest; English and Danish fluency is expected.