Maxime du Merle
@maximedumerle
International Lead CRA who drives GCP-compliant, risk-based clinical monitoring worldwide.
FranceWhat I'm looking for
I’m an International Lead CRA focused on delivering GCP-driven clinical trial monitoring across complex oncology and other therapeutic areas. Over 15 countries, I’ve managed international study monitoring, close-out, and the supervision of CRAs—working closely with international teams and vendors.
I bring strong expertise in Risk Based Monitoring, audit readiness (including FDA inspection preparation), and site oversight: qualifications, initiations, and ongoing monitoring activities. I’ve also led teams locally and previously operated at senior leadership levels as a Chief Operational Officer and Quality Assurance Manager—so I combine clinical rigor with operational excellence.
Experience
Work history, roles, and key accomplishments
International Clinical Monitoring Lead
Ixial
Jan 2023 - Dec 2025 (2 years 11 months)
Served as International Clinical Monitoring Lead for global studies, overseeing qualifications, initiations, ongoing monitoring, and close-out across oncology protocols. Managed CRO/vendor activities and supervised CRA work, supporting international study execution across 15 countries.
International Lead CRA
Ividata
Jan 2022 - Dec 2022 (11 months)
Led international clinical monitoring as Lead CRA, coordinating on-site oversight and study execution for multinational trials. Ensured GCP compliance and supported vendor and CRA supervision across complex protocols.
National Lead CRA
Excelya
Jan 2014 - Dec 2019 (5 years 11 months)
Acted as National Lead CRA for AstraZeneca, overseeing CRA monitoring activities and supporting protocol adherence across a national portfolio. Applied GCP-focused, risk-based monitoring practices to improve trial execution and site governance.
Senior CRA
Quintiles
Jan 2011 - Dec 2013 (2 years 11 months)
Worked as Senior CRA for Roche, performing on-site monitoring and documentation review to maintain GCP compliance. Supported risk-based monitoring processes and contributed to regulatory inspection preparation.
Clinical Research Associate
Clinact
Jan 2009 - Sep 2011 (2 years 8 months)
Served as Clinical Research Associate at Clinact, conducting monitoring visits and ensuring accurate, GCP-aligned trial documentation. Used CTMS and eTMF/eCRF systems to support timely reporting and issue tracking.
Clinical Research Associate
Kappa Santé
Jan 2008 - Dec 2008 (11 months)
Worked as a Clinical Research Associate at Kappa Santé, performing clinical monitoring and supporting protocol execution at study sites. Maintained GCP-aligned documentation and coordinated with site teams to support data capture quality.
Education
Degrees, certifications, and relevant coursework
ADDS - CRA Training
CRA Training Course, Clinical Research Associate (CRA)
2007 - 2007
Completed a CRA training course with ADDS in 2007.
Université de Caen
Master of Science (MSc), Food and Health Sciences
2004 - 2005
Grade: With honours
Earned an MSc in Food and Health Sciences at the Université de Caen with honours.
University of Versailles Saint-Quentin-en-Yvelines
Bachelor of Science (BSc) and Master of Science (MSc), Biology
2000 - 2004
Grade: With honours
Completed a biology degree program including a BSc and an MSc at the University of Versailles Saint-Quentin-en-Yvelines, with honours.
La Pitié-Salpêtrière (Paris VI)
First year of medical studies, Medicine
1998 - 2000
Completed the first years of medical studies at La Pitié-Salpêtrière (Paris VI).
Saint Jean de Béthune
Baccalauréat (Science track), Science
1998 - 1998
Grade: With honours
Earned the Baccalauréat in the Science track at Saint Jean de Béthune (Versailles) with honours.
Availability
Location
FranceAuthorized to work in
Job categories
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