They are seeking a Clinical Supplies individual who will manage end to end supply chain management of their clinical trial supplies across the portfolio to ensure seamless delivery to their global clinical study sites.
This is a role that will make significant impact to the organization and as a result will be a highly visible role. If you are engaged by a changeable, entrepreneurial world class scientific environment and understand the value and impact you can make on patients lives, this is role will deliver.
- Design and implement supply strategies that not only meet the requirements of the study design, the clinical study sites and the relevant regulatory authorities, but also maximise efficiency of supply
- Manage, with input from CMC and Regulatory groups, the generation and approval of label texts, certified translations (where required) and label proofs
- Contribute to the design and testing of IRT systems during study setup
- Perform drug usage forecasting across the clinical portfolio
Experience & Knowledge
- Proven experience in the provision and management of clinical trial supplies and associated activities
- Experience of design, testing, implementation and management of IRT systems for multi-regional studies
- Experience of cold chain supply management and biopharmaceuticals/ biologics
- A thorough understanding of GxPs and the global regulatory requirements relating to the labelling and supply of
- Worked in early phase clinical trials
- Knowledge and experience in Oncology
- Experience of injectable product supply
Education & Qualifications
Ideally will have a degree or higher degree in a relevant scientific discipline or equivalent industry experience.