Clinical Trials Logistics Coordinator
5 days ago
As a Clinical Drug Supply Manager at Genmab, you will play a critical role in ensuring the success of our clinical trials. You will be responsible for managing the outsourcing of packaging, labeling, and distribution of clinical trial supplies for early- and late-stage trials. The successful candidate will work closely with GMP QA and our CMOs to ensure timely packaging and labeling for our clinical trials, as well as IST and PAA programs for patients with cancer and other serious diseases.
About the Role
- Manage and coordinate drug supply and provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
- Work closely with GMP QA and CMOs to ensure timely packaging and labeling for clinical trials.
- Develop and implement efficient distribution frameworks through service providers.
- Ensure compliance with cGMP and Genmab's quality system.
Requirements
- At least 3 years' experience in handling clinical drug supply, including setting up label text and handling of ancillaries.
- Ability to manage stakeholders internally and externally.
- Experience working with CMO for clinical trial supplies.
- Training in GDP, GMP, and GCP is a requirement.
- Experience working with IST and PAA from a Sponsor perspective will be an advantage.
- Excellent communication skills in English - both oral and written.
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