Greater Paris Metropolitan Region
Medical Review / Data validation / Data Review Methodology in issue research
Clinical Trial Operation Manager (June 2016 - July 2017) Late Phase - 8 countries - 800 patients Late Phase - 8 countries - 800 patients ) - Close study follow-up with affiliates and vendors: - Overall management of activities to comply with short timelines - Patient enrolment - Crfs Completion - Monitoring, Queries & issues resolution - Collect and analysis coordination of qualitative deviations
INSTITUT GUSTAVE ROUSSY Clinical Project Manager (January 2012 - October 2015) Phase II - 8 countries - 150 patients: Pediatric oncology - Diffuse Intrinsic Pontine Glioma (DIPG) Phase I-II - 8 countries - 160 patients: Pediatric oncology - Low Grade Glioma Feasibility - Feasibility Questionnaires creation - Sites selection - Protocol review - eCRF review - Choice of service providers - Drug and Samples logistic Study Initiation - Sites Budget and contracts approvals - Co-sponsorship approvals - Development of study plans (Monitoring plan, visit report guidelines, filing/risk management plan) - Training of new team members - Active participation to co-sponsors' meeting for sites activation progress - Site initiation Conduct of the study - Manage and lead EU team for daily request - Ongoing review of study protocol deviations - Checking CRAs compliance to monitoring plan - Training team members - Checking compliance against contracted budget - Monitoring visit report review - Monitoring plan and other study guidelines creation - International follow-up with local sponsors - Steering Committee animation Sponsor Clinical Research associate including coordination (October 2010 - present) Phase II - 7 countries - 120 patients: Pediatric oncology - Neuroblastoma Phase I - 1 country - 45 patients: oncology - Solid Tumor Phase II - 1 country - 110 patients: oncology - Gynecology Phase II - 1 country - 60 patients - Radiotherapy - General on site monitoring responsibilities, site initiation visits - Contracts management - Investigators payments - eCRF, DCF management and tracking - Maintenance of study files - Protocol and amendment review - ICF Review
Clinical Research Associate Phase III - Gynecology Phase III - Kidney transplantation - General on site monitoring responsibilities, site initiation visits - Contracts management - Investigators payments - eCRF, DCF management and tracking - Maintenance of study files
Clinical Research Associate - General on site monitoring responsibilities, site initiation visits - eCRF, DCF management and tracking - Synopsis and ICF translation