The Clinical Trial Supply Manager (CTSM) is accountable for the set-up and follow-up of the logistical activities from issue of a draft concept protocol till the overall vaccine reconciliation at study end.
The scope of the work includes project management, leadership and oversight of both global and in country activities, as well as authorship at some study documents.
- For a project or a group of studies covering different projects, ensure effective interface between TRD LDP and Clinical Study Team including the Study Delivery Lead, Local Delivery Lead, Label Expert, pack-expert, Depot and Distribution Expert and their related QA partners, by providing input in study protocol, provide logistic instructions for investigational sites, informing about logistics requirements and due dates, supply issues ;
- Be the Clinical Study Team voice within TRD LDP to communicate needs and contraints in terms of logistic supply mangement & logistic support ;
- Provide input in development of the study protocol and related documents ;
- Establish operational feasibility of each new study protocol and escalate the detected feasibility issues at both Clinical Study team, Clinical Supply Operations and Portofolio Manager (PFM) ;
- Report newly planned studies and new demand in ongoing studies to TRD GMP Production planner to ensure capacity feasibility is done ;
- For each study, define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution), ensure alignment with other stakeholder's constraints and develops study logistical plan and including detailed schedule and budget ;
- Own the supply chain processes and documents. Ensure that all study related activities are operationally set-up and conducted in TRD GMP in line with approach, agreed with study team ;
- Manage and set-up the collaboration with the world-wide depots selected for the clinical study in line with local requirements defined with the countries involved in the study ;
- Study follow-up and guarantee study continuity by ensuring vaccine re-supplies are done in time according to the recruitment strategy and changing needs of the studies and countries ;
- Ensure study milestones are respected by TRD Clinical Supply Operations based on the planning information provided by the Production Planner ;
- Acts as the single point of contact for review and study timings and to (re)negotiate due dates.
- Follow up on study KPIs, identify trends and ensure problems as adressed ;
- Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes and ways of working are in place across all project and studies for all key activities of CTSM's ;
- Develop and maintain the appropriate documentation related to logistic processes, study management and the interface with other stakeholders.
- University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline ;
- First experience in clinical research and/or clinical supply management ;
- Fluency in written and spoken English, Good level of written and spoken French ;
- Clinical Project/Study knowledge ;
- Knowledge of GCP & GDP quality standards ;
- Clinical Trial Supplies Operations (Labelling/Pack/WH/Distribution) knowledge.
You will join a dynamic and international environment with enthusiastic and professional colleagues. On the top of this, you will receive a competitive salary package including attractive extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
For more information please contact me at: +31 (0)20 20 44 502 or firstname.lastname@example.org.