Project Manager Clinical Supply Chain (RE-34267365)

Project Manager Clinical Supply Chain
Breda
Biotech industry
Hybrid work model

Objective
Timely, efficient, effective and independent lead the global design and set up of clinical supply chains for the assigned clinical programs/studies.
Ensure global supplies at study start to support first subject enrolled per country cluster/depot.

Tasks
Develop and employ project management techniques to design and set up supply chains for clinical studies. This includes:
* Create and maintain project plan to ensure timely clinical study start to support first subject enrolled per country cluster/ depot
* 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 considering protocol requirements and product characteristics.
* Ensure storage and shipping capabilities plus enough capacity for finished drug product is available within company supply chain network (both internal and external) to support global study footprint.
* Design cost efficient (re)supply model to distribute finished drug product by considered risk analysis and mitigation strategy.
* 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
Performs other functions as assigned

Qualifications
Minimum Requirements
- Knowledge of clinical supply chain management
- Bachelor's degree or equivalent in logistics, business administration or life science.
- Typically, 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 3-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

Preferred Requirements
- Advanced experience in MS Office applications
- Experience in using ERP systems, preferably SAP
- Project Management certification (PMP, IPMA)