Main responsibilities:
- The IPM is responsible for overseeing per study allocated the management of Investigational Medicinal Product (IMP) / Auxiliary Medicinal Product (AxMP) / Medical Devices (MD) and other activities associated, to ensure that reception, handling, storage, distribution, reconciliation, returns, and destruction operations are performed on time and under conformance with Sanofi standard and local & international regulations. It is the main point of contact at country level for IMP management.
- The IPM has responsibilities per study allocated during the study setup, study conduct and study closure
Study Setup
- Identifies & implements efficiencies in IMP/AxMP/MD processes management, including continuous training and creation of quality documents at local and site levels (local manual*).
- Budgets IMP LCSR per study at country level.
- Organizes local kick of Meeting per study for monitoring teams oriented to specific doubts for IMP management and accountability and IMP Check list review at IMPACT System.
Study On-Going
- Manages Importation and Exportation process for all studies (eg - IMP, AxMP,).
- Oversees Depot activities (Study set-up, receptions, inventory management, shipments scheduled, labeling, returns, destruction, and equipment returned).
- Manages quality issues regarding IMP (eg - recall, temperature excursions, product technical complaints, local depot issues).
- Ensure the continuity of the local distribution of the IMP / AxMP & Ancillary material for all sites of all studies.
- Cooperates with internal and external areas at a local and corporate level (eg – CSMM, CQH, purchase, legal, outsourcing vendors).
- Supports continuously sites participating in the studies for different topics such as TMD uses, temperature excursion management, log accountability filling, and equipment searching.
- Attends Audits and Inspections for Study internally and from MoH.
Study Closure
- Performs IRT Reconciliation at country level and destruction coordination with the depot.
- Organizes Study file and archive per study.
- Organizes Study Closure at depot level.
- Experience:
A minimum of 3 years in the Pharmaceutical Industry with at least 2 in IMP management and distribution
- Soft skills:
Excellent oral and written communication skills
Negotiation & problem-solving skills
Strong ability to analyze data
Project management is a plus (experience in working in a project team and in complex environments, dealing with leading international and/or multi-cultural teams)
Risk Management orientated
Proactive and innovative mindset
- Technical skills:
Strong knowledge in clinical trial management and Clinical Supply chain
Thorough understanding of GMP, GCP & GDP
In-depth knowledge of Turkey and EU regulations and guidelines applicable to R&D IMP / AxMP / MD management
Experience in successful vendor management and oversight
Familiar with Sanofi IP management tools & systems is a plus
- Education: Pharmacist or scientific background
- Languages: EN
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