Clinical Trial Supply Assistant

For one of our client located in the Walloon Brabant, we are looking for an enthusiastic and experienced Clinical Trial Supply Assistant.

  • Do you have 3 years of experience in a similar position (CTA, …)?
  • Do you have a good level of spoken and written English and French?

If this applies to you, don't hesitate to contact us and/or send your CV!

Job Description 

As Clinical Trial Supply Assistant (CTSA) you support the CTSM in the fulfillment of his responsibilities and you provide administrative and operational support for all activities related to the logistic of clinical trial supplies.

Responsibilities 
  • For a project or a group of studies covering different projects, you give support to the Clinical Trial Supply Manager to ensure a proper study conduct and follow-up (audit, inspection, process improvement, …)
  • You are responsible to encode and maintain the protocol logistical requirements in the logistic demand system (ESR) based on the output of the logistical and randomization kick off meeting.
  • You manage task and purchase orders linked to logistical activities (depot & distribution activities), you give support to the Clinical Trial Supply Manager on managing logistical study budget.
  • You retrieve, analyze data for stock management and propose resupply strategy
  • You perform overall reconciliation of vaccines at study end and ensure proper documentation is available
  • You ensure relevant documentation is archived and posted in the electronic trial master file (eTMF) according to the Reference Model.
  • For each study, you define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution), you ensure alignment with the other stakeholder’s constraints and you develop study logistical plan and including detailed schedule and budget.
  • You act as Subject Matter Expert for one or several processes of the team. You ensure standard processes and ways of working are in place across all project and studies for all key activities of CTSAs.
  • You develop and maintain the appropriate documentation (SOPs, WIKI, guidance, and training material to support operations) related to logistic processes.
  • You Work on all types of studies according to ICH GCP and /or other ethical guidelines, policies and SOPs within defined timelines to ensure the quality of the study data with regard to clinical trial supplies.
  • You have basic knowledge on status of individual studies on which she/he is working.
  • Document Management and Administrative Support
    • You prepare & support for the operational meetings
    • You assist in design/customisation of the Study Procedures Manual and specific randomization user guide
    • You track day to day, in a proactive and autonomous manner, essential documents.
    • You create tracking tables for studies and clinical trial supplies. You maintain accurate and up-to-date information of the project e.g. expiry dates, lot status, shipment dates….
    • You provide support in trainings (creation of material for training / refresher session…).
    • You maintain e-TMF up to date
  • Operational support
    • You create study design and Supply Request in SAP:
      • Study and Logistical design
      • Supply Request for clinical trial supplies
      • Supply Request for material and biospecimen labels
  • You do any other work related to the study logistics delegated by the VSC.
  • You follow-up of clinical trial supplies and material ordering with CRA’s (LOC’s) and CTSU.
  • You do a tracking of expiry dates of clinical trial supplies and material.
  • You do a tracking of inventory in Warehouses, Transit Centres
  • You actively participate to logistical meetings with internal and external partners
Profile 
  • You have ideally 3 years of experience in a similar position (CTA, …)
  • You have a background knowledge of clinical trials (asset)
  • You have a good communication skills and Team spirit
  • You are well organized and have an eye for detail
  • You are independent worker
  • You are motivated and dynamic personality
  • You are proactive
  • You are IT tools oriented.
  • You are familiar with SAP
  • You have a good knowledge of Microsoft Word, Excel, PowerPoint
  • You are fluent in English: good written & spoken
Contact Information 

Amandine Planche
+32 10 68 53 30
amandine.planche@valesta.com

Application form : Clinical Trial Supply Assistant

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