Clinical Trial Supply Manager
The Clinical Trial Supply Manager is the TRD LDP single point of contact for the study team (Central&LOC's).
The 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.
This includes :
- the translation of study protocols into on operational demand ;
- the feasibility assessment for completion of logistical activities ;
- the definition of logistical operational strategies (supply, distribution, randomization,...) ;
- the set-up and follow-up of clinical supply related activities for a project or a group of studies
- the guaranty of alignement among the network of stakeholders, GMP operations and clinical operations (central and local) to support the delivery of clinical vaccines and ancillaries in timeat right quality and within agreed budget.
The scope of the work includes project management, leadership and oversight of both global and incountry 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)negociate due dates.
- Follow up on study KPIs, identify trends and ensure problems as adressed ;
- Ac 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 (SOP's,WIKI, guidance, training material to support operations) related to logistic processes, study management and the interface with other stakeholders.
We are looking for a profile who has a :
- 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 ;
- Coordination skills ;
- Clinical Project/Study knowledge ;
- Knowledge of GCP & GDP quality standards ;
- Clinical Trial Supplies Operations (Labelling/Pack/WH/Distribution) knowledge.
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 - Waterloo
- Nijverheidslaan 3, - Strombeek Bever