Gwenaelle Mille
About Gwenaelle Mille
Gwenaelle Mille is a Clinical Trial Manager at DURECT Corporation, where she has worked since 2016. She has extensive experience in managing clinical trials across various therapeutic areas and has held multiple roles in clinical research throughout her career.
Work at DURECT Corporation
Gwenaelle Mille has been serving as a Clinical Trial Manager at DURECT Corporation since 2016. In this role, she has overseen the study start-up processes, which include site identification, selection, initiation visits, and financial contract setup. Her tenure at DURECT spans eight years, during which she has contributed to the management of various clinical trials, ensuring compliance with regulatory standards and sponsor policies.
Previous Experience in Clinical Research
Prior to her current position, Gwenaelle Mille held various roles in clinical research. She worked as a Senior Clinical Research Associate at Pharm-Olam International from 2012 to 2013. Additionally, she served as a Clinical Research Coordinator at Rush University Medical Center from 2015 to 2016 and at SRG Woolf Group for three months in 2007. Her experience also includes positions as a Clinical Research Associate at Fujisawa GmbH and Essex Pharma GmbH in Germany, as well as at Pharm-Olam International in the Greater Chicago Area.
Education and Expertise
Gwenaelle Mille studied at Pierre and Marie Curie University, where she achieved a DU FARC from 1996 to 1997. She also obtained a DEUG B from Université Paris Cité between 1994 and 1996. She possesses strong expertise in electronic data capture systems, including Datatrak, DataLab, and Inform. Her knowledge extends to compliance with GCP/ICH, FDA regulations, and sponsor policies.
Clinical Trial Management Skills
Gwenaelle Mille has extensive experience managing clinical trials across multiple therapeutic areas, including Cardiovascular, Dermatology, Endocrinology, Gynecology, Hepatology, Immunology, Infectious Disease, Neurology, Oncology, and Psychiatry. She has conducted feasibility studies to assess therapeutic indications and the capabilities of investigators to conduct trials. Her background includes training and working as a Clinical Research Coordinator.
Contributions to Clinical Trials
In her career, Gwenaelle Mille contributed to a Phase 2b trial focused on alcohol-associated hepatitis, evaluating the safety and efficacy of Larsucosterol treatment. This involvement highlights her role in advancing clinical research and her commitment to improving patient outcomes through rigorous trial management.