Clinical Trial Supply Manager/Associate NOVJP00026223+26224 (m/f)

REFERENZNUMMER:

373468/11

IHRE AUFGABEN:

-Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management
-Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule
-Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections with appropriate overage and by using defined processes and systems
-Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots
-Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g. labels, packaging, distribution and comparators)

IHRE QUALIFIKATIONEN:

-Degree in science, engineering or equivalent
-Fluent in English
-Some years of practical experience in chemical / pharmaceutical industry, some years of experience in field of expertise
-Good expertise in related field.
-Good knowledge about the Drug Development process
-Basic project management, good organization and planning skills
-Knowledge of relevant regulations (e.g. GMP, HSE etc.)

WEITERE QUALIFIKATIONEN:

Clinical trial assistant