Brahmi S.

Management of Investigational Medicinal Products (IMPs) and devices for phase I to IV international clinical studies (double-blind, comparator and standard of care sourcing). In charge of performing study set-up, follow-up and reconciliation tasks related to clinical supplies from the receipt of a clinical protocol until the end of the study. Responsibilities:

- Capture of the clinical requirements (patient recruitment curve, country list...) in the protocol

- Forecasting IMP/NIMP/ancillary needs based on protocol design

- Ensure that regulatory & GMP requirements are met for IMP supply, IMP needs calculation, packaging design, IMP management and distribution

- Work with relevant departments to create master labels for each study & support relabelling process

- Set-up the distribution strategy and adjustment of the logistic of distribution according to patient recruitment

- Monitor distribution operations (shipment of IMP to investigational sites, re supply, transfers, returns)

- Monitor IMP stocks at corporate, local depots and site level

- Lead operational study meetings & participate to clinical meetings

- Check consistency of IMP needs with clinical current data and update IMP needs, master study schedule for packaging and distribution