About Lynda
French
Native or bilingual
English
Fluent
Experience
- ImmutepClinical Trail ManagerPHARMACEUTICALS INDUSTRYJuly 2024 - Today (1 year and 11 months)HighlightsExperienced Clinical Research professional with demonstrated history in Clinical Operations and Program Management, including:•Project Management in the biotech industry leading the program team at operational level•Line Management, people development, and team growth•Managing cross-functional project teams and working in a matrix structure in biotech as well as pharma companies•Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies•Study Management : oversee all aspects of trial execution−Site feasibility, selection, start-up, monitoring, and regulatory submissions−Budget management and financial oversight−CRO and vendor management, ensuring contracted deliverables are met−Cross-functional collaboration with internal teams and external stakeholders−Risk management, quality oversight, and compliance with regulatory standardsAuthority inspections preparation – ANSM, and FDA•Various therapeutic indications – oncology (predominantly), psoriasis, Leukemia - Oncology in pediatric population, infectious diseases, Medical Devices.Work experienceKey Achievements•Successfully managed a multi-site oncology clinical trial, delivered on time and within budget.•Streamlined risk assessment processes, reducing response times.•Supported ANSM and FDA inspections with outstanding preparation and follow-up results
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Education
- Master’s degree in clinical project managementParis University2019