Description
We are recruiting for a Clinical Trial Supply Manager who will be responsible for the definition and execution of an optimal clinical trial supply strategy. You will be responsible for the effective risk management to ensure supply continuity to patients. You will lead and manage all projects and participate in cross-functional teams.Responsibilities:
- Define the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
- Review overall clinical trial protocol, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
- Create and maintain complete and accurate clinical supply demand for studies.
- Create and drive finalization of the packaging design and a comprehensive label strategy for all participating countries in the clinical trial.
- Define clinical supply parameters and initiate subsequent updates throughout the duration of the clinical trial
- Develop and execute a trial-level project plan together with all other relevant roles.
- Identify, assess and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
- Collaborate with all relevant line function partners for country submission and approval timelines (including INDIMPD amendment) to develop optimal supply strategy.
- Generate 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.
- Develop, maintain and execute 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.
Requirements:
- BSc in Science, Engineering or equivalent.
- 5 years of practical experience
- Good knowledge about the Drug Development process
- Project management, good organization and planning skills
Kontakt: Luchele Mendes ()
Michael Bailey International is acting as an Employment Business in relation to this vacancy.