Beschreibung
Clinical Drug Supply Manager - IRT/IWRS expert (6 months)For my client, a cancer care company I am currently searching for a Clinical Drug Supply Manager for a 6 month project in the Ticino area.
Your tasks:
- Clinical trial supply needs forecasting encompassing pre-determined algorithms, review and approval of IRT documentation, risk based supply and re-supply methodology application, packaging/labelling and global distribution set-up
- Involvement in the early set up of IWRS, communicating to the vendor the user requirement based on study design (clinical supply specification according on the need from clinical operations and SDM).
- Interaction with IWRS vendor for configuration implementation of all distribution requirement s as required by the protocol (countries set-up, depot set-up) regarding drug distribution activities that should be managed through the system. B
- Expert Engagement of all automatic distribution related parameters: Do Not Dispense, Do Not Include, Do Not Ship, Order Trigger Levels, and Resupply To Levels
- Design, Implementation, control and review of all distribution parameters for optimal IMP (Investigational Medicinal Product) shipments (shipment frequency, IMP number of units per shipment, temperature control)
- Design, review and finalization of IWRS Specification with the provider, according to study requirements from all the areas involved (internally and externally)
- Design & perform customized User Acceptance Testing (UAT) in accordance with IWRS Vendor and Sponsor
- IMP release in the IWRS system following the Certificate of Compliance/Analysis provision
- Oversee bulk inventories at local depots according to distribution rate in order to avoid the stock to run out
- Management of temperature excursions events during supplies, including interaction with site staff & Pharmaceutical Development manager for evaluation of the excursion's impact, release, quarantine or replacement of the supplies
- Management of IWRS generated alerts, including supplies damages during transportation or storage
- Oversee the acknowledgement of receipt of supplies at clinical sites, including interaction with site staff for any delay/problem with upload of the supplies in the system
- Collection and archive of IWRS generated reports to be used for drug global management/accountability and to be integrated into study's TMF
Your qualifications:
- Minimum 3 years of experience in a similar capacity
- Ability to prioritize multiple tasks and manage time efficiently
- Fluent English, Italian an advantange
- Swiss resident or EU national
If this role is of interest to you, please send your CV in Word format including your hourly rate expectation for immediate consideration. You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: Clinical Drug Supply Manager, IRT, Item Response Theory, IWRS, Interactive Web Response System, UAT, IMP. Supply Chain, Ticino