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Clinical supply manager - Belgium  

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Posted on : 02 May 2017

Project Description

Tasks

Missions :

 

The Clinical Supply Manager is the main point of contact for clinical supplies between Clinical Operations and the Clinical Trial Supply Unit.

 

The CSM is responsible for the supplies used in a clinical trial from start to end, from forecasting until delivery onsite and beyond (IMP reconciliation)

 

 

  • Point of contact for clinical (central and region) for study related logistic aspects
  • Review protocol
  • Coordinate the feasibility assessment and risk analysis/mitigation for all logistic aspects of a clinical trial
  • Define  the packaging and randomisation strategy
  • Define  the shipment and resupply strategy
  • Define  the labelling strategy
  • Coordinate the Demand Management in SAP
  • Coordinate the Demand Management of any non-standard study-related requests outside SAP
  • Review any study specific procedures, documents, presentations, …
  • Assess and find agreement on delivery needs with client and communicate corresponding timelines and any changes to the delivery dates to the client
  • Ensure operational activities are timely included and updated as applicable in the Planning
  • Point of Contact for study related questions, process clarifications/deviations, training needs, complaints, quality,…
  • Participation in projects as lead or contributor as assigned by Management
  • GCP audit Coordination (study related)
  • Continuous improvement: raise process improvements, developments …
  • Coordinate SOP deviations (study-related)

Requirements

Master degree in Sciences or equivalent, or other relevant discipline

At least 3 years experience in Project Management

Good Clinical Study knowledge (3 to 5 years of experience)

Strong knowledge of GCP/GMP/quality standards

Knowledge of Clinical Trial Supplies Operations (Labelling/Pack/WH/Distribution)

Product & Production knowledge is an asset

Good level of written and spoken English