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Maria Koutsopoulou

Maria Koutsopoulou is heading Global Development Operations (GDO) within the healthcare business of Merck KGaA, Darmstadt, Germany. In this role, Maria leads and manages all operations related to the conduct of Merck KGaA/EMD Serono clinical study portfolio – from Phase I to Phase IV studies, including investigator-sponsored studies (ISSs), in all therapeutic areas. Maria’s remit also includes bringing highly innovative, patient-centric operational designs and approaches to the development programs while overseeing operational and clinical data flow as well as utilizing technology and digital innovations to accelerate and simplify studies across the portfolio.

Maria has more than 25 years of global clinical development experience in both the CRO and pharma industry, from early development to post-launch. She has a keen focus on accelerating drug development, elevating the R&D efficiency to the next level and she brings an entrepreneurial and innovative spirit to serve patients in need. In previous roles, she successfully led various clinical operations functions at the local, regional, and global levels. Maria comes with a wide range of international experience after serving in leadership roles in China, the U.S., and Europe. Maria joined Merck KGaA, Darmstadt, Germany in 2007 and was most recently Head of Clinical Trial Execution. Maria received her undergraduate degree in Biomedical Sciences from the University of Applied Sciences, in Athens Greece, and her degree in Applied Languages & International Relations from the University of Strasbourg, France.


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