Clinical Trial Supply Manager (m/f)

REFERENZNUMMER:

353706/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Drug supply manager