For this position, candidates with Commercial Supply Chain vendor management background that would have the interest on exploring the clinical supplies world are preferable.
The aim is to have a long term mission , with challenges not only on day-today activities but also to participate on projects and participate on improving structural changes on ways of working and thinking. The candidate would accept the challenge to work on an environment that is not stable, balancing his skills to solve hurdles and emergencies and at the same time, participating on the creation of robust process and ways of working which will create the basis for the future success of the department.
Scope: all clinical trials (phase 1 – 4)
The Outsourcing Coordinator is responsible but not exclusively for:
Coordination and follow up on outsourced activities as well as outsourcing forecasts for CTS. The end goal is to ensure availability of on time and in full availability of IMPs or other materials necessary to their customers, the clinical trial planning team
Participate in study setup meetings and ensure the outsourcing process is well understood by all internal stakeholders and ensure that what will be delivered by the CMO is in accordance with what is required by the study.
- Provide information on study design and variables with selected CMO. Liaise with CMO’s to set up planning for study production runs and ensure successful and on time delivery of the product.
- Act as point of contact for CMO’s and ensure any concerns/issues/deviations/complaints are addressed and action plans are defined. After, lead the action plan to make sure all actions are fulfilled considering the sense of urgency and escalating issues when needed.
- Maintain strong relationships with external and internal stakeholders
- Closely monitor day-to-day activities to ensure all packaging components are available on time
- Review pre-production documentation, request batch records and ensure requested samples are available on time for QA/QP to perform batch releases
- Participate in reconciliation and destruction exercises for materials at CMO’s
- Continuously search for improvement opportunities and work with Outsourcing Manager on implementation
- Oversee and guarantee that all the purchasing steps are up to date
- He / She is also responsible for the procurement of comparators
At least 1 year of experience on CMO management or sourcing, preferably in the pharmaceutical industry, with an understanding of demand, supply & logistics principles and clinical development processes
Fluent in English (written and spoken)
Experience in project management or supply chain planning
Intermediate knowledge of office apps (specially excel)
Process/result oriented mindset
Experience in SAP
Knowledge of working in a GMP environment
wat bieden wij?
We offer an attractive salary with extra-legal advantages :