MONTPELLIER
For multinational and national studies:
- Coordination of studies for the french sites
-Management of a multinational study as legal representative of the sponsor in Europe (agreement, financial aspects, amendment,...)
- Participation of clinical research meetings
For national studies:
- Conception of trials documents in collaboration with the project coordinator (PI) in compliance with regulatory requirements and ICH guidelines.
- Involved in regulatory submissions to the french competent authorities (ANSM, EC, CNIL).
- Involved in global Project Management of clinical trials (problems identification, superior advise of clinical trials issues and setting up of corrective actions...).
- Planification and management of project meetings with collaborators of the study
- Creation and follow-up of financial and study tracking documents, agreements.
Transverse missions:
- Improve the quality management system (writing SOP,…) in collaboration with the Quality Manager.
Skills:
- Management of institutional clinical studies (national/international interventional studies on cell therapy, drugs, medical device, phases I to III) sponsored by Montpellier University Hospital or Montreal Health Innovation Coordinating Center = > sense of communication and good relationships with investigator sites and sponsor (when it's applicable).
- Activities monitoring (feasibility studies, training of investigational sites and pharmacies, initiation visits, remote and on-site monitoring of clinical data on-site, close-out visits) according to internal SOP and ICH/BPC guidelines.
- Pharmacy Visits (drugs compliance control, drugs/medical devices storage conditions checking…).
- Recognized knowledges in Cardiology, Clinical physiologie, Pneumology, Rheumatology.
- Pharmacovigilance : AE, SAE, SUSAR and Safety management.
Mes compétences :
Qualité
Audit
Recherche clinique
