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.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Spanish
Conversational

Workplace preferences

Can work on-site

Nantes (up to 15km)

Seagen SAS France
Senior Manager, Clinical Trials
January 2022 - January 2024 (2 years)
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
January 2021 - January 2022 (1 year)
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
January 2020 - January 2021 (1 year)
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