The Associate Clinical Supply Chain manages clinical study set up process within GMP, GDocP and GDP regulated supply chain. The role supports the project managers clinical supply chain to timely, efficient and effective lead the global design and set up of clinical supply chains for the assigned clinical programs.
Responsibilities
- Master Data Management in ERP (SAP)
- Central focus point for ERP (SAP) readiness:
- Initiate clinical label material requests;
- Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures timely availability to adhere to overall project timelines
- Ensures setup of Study Design Tables
- Setup Activities
- Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries.
- Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial
- Creates and maintains third party depot plans and cross docks to support global study footprint
- Reporting
- Maintains Metrics for Global Setup lead team
- Contributes to monthly Workforce planning cycle
Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
Minimum Requirements
- Bachelor degree or equivalent in logistics, business administration or life science.
- Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry,
- Typically relevant working experience in an international and regulated environment
- Understanding of fundamentals of logistics/supply chain principles (especially BOM)
- Experience in planning
- Experience in project management techniques
- Advanced experience in MS Office applications (Word, Excel)
- Fluency in English, both in oral and written communication
- High quality standards with regards to work
- Ability to set priorities and timely escalation
Preferred Requirements
- Knowledge of clinical supply chain management
- General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, International Conference on Harmonization (ICH) guidelines, Clinical Trial Directive)
- Experience in using SAP
- Excellent communicating and facilitating issue resolution skills
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info