Description
We are looking for a
Clinical Trial Supply Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Ensure timely delivery of clinical trial supplies for assigned projects and studies
- Agree on project scope and perform risk assessment and elaborate contingency
- Advising customers from the clinical development and medical marketing functions with regard to packaging and labelling of study drugs for clinical purpose
- Development of study specific packaging and labelling configuration
- Coordinate the production activities with regard to primary packaging (when appropriate), secondary packaging, labelling, and randomization at the supplier level
- Ensure that the operative clinical trial supply tasks are delegated to the service providers and minimize own involvement on the operational level
- Ensure coordination between all functions involved in clinical supply such as Clinical Development, Medical Marketing, Biometrics, Regulatory Affairs, Quality Management, Technical Operations etc.
- Ensure proper batch allocation and compliant process of packaging and labelling activities
- Set-up the worldwide study distribution to ensure proper distribution to the final consignees (investigational sites), including the availability of import license or notifications (study/country/site specific)
- Work on organizational projects aiming at improving the packaging, labelling, and distribution processes in terms of quality, productivity, and costs
- Organize proper hand-over of projects including documentation as filed in the project specific TMF
Your qualifications
- University degree or equivalent working experience
- Working experience in Clinical Trial Supply Management
- Expert in international current GMP, GDP and GCP regulations
- Excellent command of common study management tools
- Excellent command of English, additional language is advantageous
Skills:
- Drug supply manager