For one of our clients in the area of Antwerp, we are looking for a Trial Supply Manager.
As TSM you are responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines.
- Do you have experience in clinical research or logistics?
- Are you action-oriented, flexible and stress resistant?
- Do you like a fast paced job with lots of variation?
Then don't hesitate to apply...
As Trial Supply Manager you are responsible for the management of all clinical supplies during trial execution. Activities include all in-house and outsourced manufacturing of clinical supplies (Drug substance, Drug Product, Packaged and Labeled Clinical Supplies). Furthermore the supply chain group handles demand forecasting, supply planning, and global distribution. Through a global network and organization (US, Switzerland, Belgium, Ireland, Netherlands, India), they are accountable for the manufacturing and scale-up of small and large molecules products in development and low volume commercial supply. They secure the supply to more than 60.000 patients in more than 330 clinical trials every year.
As Trial Supply Manager you will be responsible for:
- Planning and inventory management during the execution phase of clinical trials consistent with GCP guidelines
- Building and executing supply strategies in view of changes in trial execution
- Ensuring a seamless transition from study design phase and assessing clinical study recruitment rates, forecasting for kit demand planning and ensuring supply planning is adopted accordingly
- Utilizing business tools to handle inventories and ensuring on-time delivery with minimal overage of clinical supplies
- Issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution) and establish and modify trial specific distribution agreements
- Participating as a member of appropriate GCDO clinical trial team and collaborating with your partners to ensure customer satisfaction, interfacing with Global Trial Managers
- Developing excellent working relationships with the other groups within Supply Management
- Running trial supply specific budget and supporting business process improvement initiatives during trial execution
- You have a minimum of 4 years of relevant experience in a supply chain functional area (make, source, plan, deliver), preferable in the clinical supply chain or in clinical research
- Preference for people who use clinical supply demand management/planning tools (e.g., tcVisualize, IVRS, OMP+) or equivalent supply chain planning systems (SAP/ERP)
- You know how to work in S&OP processes
- You are experienced with the following functions: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management
- General knowledge of GMP or GCP principles are preferred
- You are willing to handle inventory and define need for material and capacity to address expected demand; ability to execute resulting plans
- Advanced skills with MS Excel (pivot tables, graphs, conditional formatting, etc.) is required
- You demonstrate awareness of pack/label and logistics operations and uses knowledge effectively planning and execution activities
- You are able to evaluate risks based on sound business analyses
- You can handle study specific budgets and communicate impact of changes
- You like to lead complex projects
- You have excellent written and verbal communication skills with the ability to communicate complex issues to internal and external partners driving effective decision making
- You are fluent in English
015 21 11 04