Ref #: 32855

Employment type: Permanent - Full-Time

Location: Brazil

Posted: 07-Oct-2021

Description

The Investigational Product Specialist will assist with the management of the Investigational Medicinal Products (IMP) and non-IMP inventory from receipt thru destruction. This responsibility is performed within the CSU and works with study Monitoring Teams, distribution warehouse/depot and/or third party group.

•The IP Specialist will be responsible of the day-to-day processing of US CSU IP inventory is as per local SOPs and procedures
•Coordinates and collates the receipt, storage, inventory, shipment, acknowledgment of receipt, return, reconciliation and destruction of IMP/non-IMP with the Warehouse, study Monitoring Teams, CTOMs and external partners
•Ensures the local study files owned by the IP Manager are complete as per local SOPs and are audit ready
•Monitor IP tracking tables (IPTT) or CSMS (Clinical Supply Management System) to ensure ongoing completion by monitoring teams for site shipment and reciept, return and destruction.
• Activity also includes tracking temperature excursions. Provide data entry support as needed for both
IPTT & CSMS.
• Support reading of temperature monitoring devices and printing of reports
• Under the oversight of the IP Mgr. assist with IMP tasks associated with an OUTSOURCED STUDY
being handled by a CRO