For one of our clients, located in Breda, we are currently looking for a "Project Manager Clinical Supply Chain".
We are looking for a candidate for the Clinical Supply Chain team. The team is responsible for the planning, set up and inventory for clinical studies. The team operates on a global basis, working from both Breda and the USA .
We are looking for a candidate with 5+ years of experience in a similar work environment. Key words are Supply Chain, Inventory Management, Pharma/Biotech and Clinical Research Management.
The Project Manager, Clinical Supply Chain is responsible for leading the global design and set up of end to end customized clinical supply chains in support of the assigned clinical programs/studies in a timely, efficient, effective and independent manner.
This role is also responsible for partnering with several cross functional stakeholders such as early development, global development organization, global regulatory and product development teams, device engineering, clinical artwork team and clinical demand and inventory planning team. In addition, the Project Manager, Clinical Supply Chain will ensure supply for global clinical trial to support first subject enrolled plus provide robust inventory management tools for the clinical demand and inventory planning team.
- Develop and employ project management techniques to design and set up supply chains for clinical studies.
- Create and maintain project plan to ensure timely clinical study start to support first subject enrolled.
- Create and maintain study forecast for finished drug product in applicable systems to support clinical study start.
- Design optimal packaging configuration for finished drug product taking into account protocol requirements and product characteristics.
- Ensure storage and shipping capabilities plus sufficient capacity for finished drug product is available within the supply chain network (both internal and external) to support global study footprint.
- Design cost efficient (re)supply model to distribute finished drug product via applying risk analysis and mitigation strategy.
- Ensure efficient and smooth hand-over to clinical demand and inventory planning team.
- Facilitate the phase in phase out strategy for new medicinal product introduction, such as running scenario's, impact on study demand and set up activities for formulation and device introductions.
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Doctorate degree OR Master's degree and 2 years of logistics, business administration or life science experience OR Bachelor's degree and 4 years of logistics, business administration or life science experience
- Knowledge of clinical supply chain management
- 5 year's relevant working experience, preferably in the biotechnology or pharmaceutical industry, with an in-depth knowledge of supply chain management and clinical research management principles.
- At minimum 5 year experience in project leadership and project management techniques in an international and regulated environment
- General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, ICH guidelines, Clinical Trial Directive)
- Fluency in English, both verbal and written communication
- Advanced experience in MS Office applications
- Experience in using ERP systems, preferably SAP
- Project Management certification (PMP, IPMA)
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16348