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Clinical Trial IMP Logistics & Compliance Specialist (M/F/D)
Tasks:
Coordinate international logistics of IMPs, its precursors (e.g. unlabeled finished product), test samples and reference samples, ensuring timely and compliant delivery to project stakeholders, including CMOs, storage providers, test laboratories, clinical sites
Manage import/export processes between EU countries and the US, including country-specific regulatory requirements.
Prepare and submit documentation for import permits, CDC permits, and customs clearance.
Ensure compliance with IATA regulations for the transport of dangerous goods, including infectious and genetically modified substances.
Maintain oversight of temperature-controlled shipments and chain-of-custody documentation.
Collaborate with CROs, sponsors, and regulatory authorities to resolve logistical and regulatory challenges.
Qualification:
Proven experience in clinical trial logistics or pharmaceutical supply chain management.
In-depth knowledge of EU and US import/export regulations for IMPs.
Certification or working knowledge of IATA Dangerous Goods Regulations (DGR).
Familiarity with GxP, ICH-GCP, and other relevant regulatory frameworks.
Requirements:
Start: asap, latest 3rd of November
Duration: 5 months
Capacity: 2-3 days per week
Location: remote
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