Archiviertes Projekt - Clinical Trial Supply Manager
Firmenname für PREMIUM-Mitglieder sichtbar
* Definition and execution of optimal clinical trial supply strategy with regards to packaging design, technical and timeline feasibility, efficiency, and risk management.
* Reviewing clinical trial protocol and provides input to develop optimal packaging design, clinical trial supply design, and visit schedule.
* Creating and maintaining 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.
* Identification, assessment and proactive communication of supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
* Collaboration with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy.
* Generation of optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Responsible for shipments of IMPs from central depot to regional hubs and local depots.
* Development, maintenance and execution of an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
* 5+ years of practical experience in chemical/pharmaceutical Industry, 3 years of experience in field of expertise
* Basic project management , good organization and planning skills
* Knowledge of relevant regulations (e.g. GMP, HSE etc.)
* Demonstrates problem-solving and idea generation skills
* Candidates from supply chain are welcome
* Strong SAP experience along with being system savvy, having strong planning skills, operational excellence & discipline.
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