Vaccine Supply Coordinator

One of our clients, an international company in the pharmaceutical industru currently requires a Vaccine Supply Coordinator

Start: ASAP
Lenght: min until 31/12/2016
Location: South of Brussels

Role:

Vaccine Supply Coordinator (VSC) is the key point of contact between the Study Delivery Lead (SDL) and the Clinical Trial Supply Unit (CTSU), from Industrialization
The VSC defines and implements the optimized strategy of packaging and shipment of Supplies for clinical trials, from beginning to end, in compliance with ICH-GCP/GMP guidelines and clients policies/SOPs/guidances

Tasks:

- Manage Clinical trial supplies for all types of studies (Phase I to Phase III, collaborative, multi country) to ensure the delivery of adequate clinical Supplies within defined timelines.
- Coordinate and consolidate the Study Supply needs in conjunction with CTSU, PM and Clinical Team, to ensure adequate and sufficient forecasting of vaccines and drug product,

comparators and forecasting of packaging workload (ie supply strategy, planning).
Collaborate closely with CTSU in regards to shipments dates, lots allocation, labelling timelines, clinical study feasibility analysis, and IMP forecasting for a specific study.

- Review the clinical trial protocols with regard to regulatory and GMP requirements, CMC issues, Clinical Trial Supply aspects and randomization system.

Analyse and evaluate the feasibility and consequences of design proposed in regards to clinical trial supplies (double blind lots&) and randomization system. Develop Pharmacy manual (Study Procedure Manual).

- Design finished IMP through translation of the protocol into packaging and labelling requirements, ensuring a proper balance between the feasibility of the technical aspects, and an optimally designed clinical presentation.

Responsible to create, approve and follow up the supply request in the official system (ESR/SAP).

- Collaborate with the Local Study Contact for review and approval of Label Master Sheet, at local level, in due time
- Assure adequate and sufficient supply of IMP and material (if applicable) at central/local depots and Investigator sites at any time during trial duration.
- Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical sites.
- Prepare the IRT/IVRS loading request with the statistician and Study team, review/validate the application and develop study specific user guide.
- Initiate and drive the Randomization kick-off meeting and vaccine requirements meetings.
- Define the trigger levels for the depots/sites with the randomization system (to be able to monitor the IMP inventory and expiry dates).
- Participates to Investigators/Monitors meeting for the studies they have been assigned to, present all logistical aspects of a study (including cold chain management), organize workshop sessions as appropriate.
- Give training to LOC on cold chain and logistics whenever deemed necessary by the Study Management team.
- Whenever needed, coordinates with study management team the return and destruction of supplies.
- Have detailed knowledge and view of his/her studies in order to be the reference person for all vaccine supply related issues within the Clinical Project Team.
- Take part to process/tools development/improvement initiatives related to vaccine supply.
- Promote sharing of Best Practices.

Tags: Vaccine, "Supply Chain", "Supply Coordinator", "Study Delivery", "Clinical Trial","Study Management", "Clinical Study"