Clinical Study Manager & Cra
Montpellier, Occitanie, France
Management of a portfolio of research projects promoted by the institution under financial, regulatory and monitoring aspects : • Preparation, conduct and follow up of regulatory submissions to Ethics Committees • Conception of trial documents in collaboration with the project coordinator (PI) in compliance with regulatory requirements and ICH guidelines • Planification and management of project meetings with study collaborators (interaction with Data Managers, Investigator teams, Methodologist)• Set up and follow the circuit of study products, samples• Preparation, conduct, follow up and close-out studies in France• Meeting with CRAs, relationship with the sites• Management of trial budget for France• Manage deviations and propose appropriate solutions• AE/SAE verification and follow-up notification with phamacovigilance data• Monitoring reports, confirmation and follow-up letters• Management and archiving of study documentation and regulatory documents