Description

I am a Senior Global Clinical Project Manager with over 13 years’ experience leading international Phase I–IIIb clinical trials in Oncology, Neurology, and Immunology for pharma and CRO organizations. I provide strategic oversight and hands-on leadership in global project management, clinical teams supervision, risk-based monitoring, and patient/site-centric recruitment strategies. I help sponsors and CROs achieve operational excellence by ensuring studies are delivered on time, with high quality, and in full regulatory compliance.

Let's connect to discuss how I can support your team.

Domaines d’expertise

Langues

Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Espagnol
Capacité professionnelle limitée

Préférences en matière de lieu de travail

Accepte de travailler sur site

Nantes (jusqu’à 15 km)

Seagen SAS France
Senior Manager, Clinical Trials
janvier 2022 - janvier 2024 (2 ans)
Nantes, France
Assignment: Pivotal Phase III oncology trial
• Provided global and regional operational leadership during study start-up and execution.
• Directed Clinical Teams, ensuring site readiness, quality oversight, and risk-based performance monitoring.
• Partnered with cross-functional stakeholders (Regulatory, Legal, Medical Affairs, Pharmacovigilance, Data Management) and CROs to ensure compliance and timely delivery.
• Designed and implemented site performance oversight strategies (KPIs, dashboards, RBQM) to proactively identify and mitigate risks.
• Mentored and guided CTMs/aCTMs, fostering accountability and delivery focus.
• Supported process improvement initiatives enhancing efficiency, speed, and quality.
Global Clinical Study Management Clinical Teams Leadership Site Performance Oversight Risk-Based Quality Management & Monitoring Regulatory Compliance
Parexel International
Senior Clinical Operation Leader
janvier 2021 - janvier 2022 (1 an)
Nantes, France
Assignment: Seagen, Phase III oncology trial – enrollment & retention
• Served as Protocol Lead, accountable for study delivery across multiple geographies.
• Oversaw clinical teams activities: site engagement, patient recruitment/retention, issue escalation.
• Championed patient-centric strategies, collaborating with CROs and site teams to optimize enrollment and improve patient experience.
• Designed and delivered training to internal teams and sites, strengthening study management capabilities.
• Contributed to lessons learned and best practice guidance, supporting process optimization and operational excellence initiatives.
• Prepared and supported audits and inspections, ensuring inspection readiness and compliance across countries.
Patient & Site-Centric Recruitment Strategies Site Performance Oversight Strategic Thinking & Influencing Skills
Parexel International
Clinical Operation Leader
janvier 2020 - janvier 2021 (1 an)
Nantes, France
Assignment: Seagen, Phase III oncology trial – start-up (EU & APAC scope)
• Led cross-regional teams (EU & APAC) during study start-up, coordinating ~100 sites worldwide and ensuring consistency in delivery.
• Designed and implemented site selection and monitoring strategies, aligning with CRO/vendor partners and global study leadership.
• Oversaw clinical teams activities and site readiness, ensuring timelines, quality standards, and risk-based approaches were maintained.
• Developed and maintained study plans, tools, and forms, promoting harmonization across regions and vendors.
• Provided study-specific training and mentoring to internal teams and site staff, enhancing operational capabilities.
• Acted as escalation point for site-level issues, ensuring resolution through data-driven oversight and stakeholder collaboration.
• Contributed to best practice sharing and process optimization, supporting efficiency and operational excellence across projects.
Site Performance Oversight Patient & Site-Centric Recruitment Strategies