À propos de Lynda
Clinical Trial Manager | Clinical Research Consultant | Expert in Biotech, Oncology , immunology & Rare Diseases
With 8+ years of experience in clinical research — from CRA to Global Clinical Trial Manager — I bring a 360° vision of early-phase development, inspection readiness, and vendor oversight.
I offer:
Operational and strategic support in clinical trial management
TMF optimization and audit readiness
Mentoring/coaching for junior CTMs and CRAs
Short- or long-term freelance missions, remote or hybrid
I bring a hands-on, proactive, and results-driven approach, combining regulatory knowledge with operational excellence.
Based in Paris, open to international opportunities.
Let’s connect to discuss how I can support your team!
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Accepte de travailler sur site
Paris (jusqu’à 50 km)
Expériences
- ImmutepClinical Trail ManagerINDUSTRIE PHARMACEUTIQUEjuillet 2024 - Aujourd'hui (1 an et 11 mois)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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Formations
- Master’s degree in clinical project managementParis University2019