For one of our clients located in the Walloon Brabant, we are looking for an experienced Clinical Trial Supply Assistant.
- Do you have a bachelor degree?
- Do you have a first experience as a Clinical Trial Assistant or as a Clinical Trial Supply Assistant?
- Are you fluent in English?
Then, you might be the candidate we are looking for.
The Clinical Trial Supply Assistant (CTSA) supports the Clinical Trial Supply Manager in the fulfillment of his responsibilities.
- For a project or a group of studies covering different projects, you give support to the Clinical Trial Supply Manager to ensure 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 based on the output of the logistical and randomization kick-off meeting.
- You manage tasks 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 supply 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), ensure alignment with the other stakeholder’s constraints and develops 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 related to logistic processes.
- You have a bachelor degree and the first experience in a clinical study environment.
- You have a good understanding of the clinical research and clinical trial conduct, ideally in supplies management.
- You have a good knowledge of GCP/GMP/quality standards
- You have a good knowledge of Clinical Trial Supplies Operations (Labelling/Pack/WH/Distribution) is an asset
- You have good communication skills.
- You are able to manage priorities, performance targets and project initiatives in a global environment.
- You are fluent in English (French is an asset)
+32 10 68 53 30