Clinical Trial Supply Manager
The Clinical Trial Supply Manager (CTSM) represents product supply in the Clinical Study Teams and drives the development and execution of effective product supply strategies in close collaboration with various key stakeholders. This role provides an opportunity to design and implement effective processes within a fast‐growing organization.
Key Accountabilities and Responsibilities:
- Represents product supply in the Clinical Study Team;
- Drives the development of tailored clinical trial supply strategies aligned with the relevant clinical trial protocol;
- Creates and maintains complete and accurate clinical supply demand for clinical studies in alignment with protocol requirements, key study parameters and milestones, patient projections;
- Drives the processes necessary for IRT set-up, conduct and close-out from a clinical trial supplies perspective;
- Develops and executes detailed clinical trial supply project plans in close collaboration with stakeholders and in compliance with GxP requirements, local regulations and argenx processes;
- Drives the development of a study specific pharmacy manual and other relevant guides in close collaboration with Clinical Study Team and CMC team;
- Actively track drug inventory and visualizes active drug consumption versus projected forecast;
- Contributes to planning and organization of global product manufacturing activities;
- Provides logistics support to the manufacturing team;
- Responsible for management of external clinical trial supply vendors and distributors;
- Responsible for collecting, registering and archiving information and documents in accordance with the applicable GxP guidelines for clinical studies (TMF, eTMF);
- Responsible to consolidate, maintain and track the clinical trial budget.
Qualifications and Skills:
- Master’s degree in a scientific discipline or equivalent through education and experience;
- Minimum 4 years’ experience in field of clinical trial supplies;
- Knowledge of GxP regulatory requirements;
- Quality conscience attitude; can do mentality;
- Project management skills, good organization and planning skills;
- Strong communication skills and able to build relationship with business partners and to work effectively together with others;
- Flexible attitude, capable of picking up the tasks that require attention;
- Working knowledge with MS Office package;
- Fluent in English – our working language.
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