With 20 years in diverse areas of the pharmaceutical industry, Emmanuel Prades has considerable expertise in project management for the clinical operations processes.
Emmanuel is responsible for the design & implementation of global regulatory strategies, implementation of clinical development plans, review of clinical trial protocols, safety efficacy evaluation, Risk Management plans for Clinical trials, INDs, NDAs & MAAs.
Emmanuel has significant experience in the management of international clinical studies (pre, post market. Device/feature validation, research studies) from protocol writing to report. He has worked on submission files management. investigator meeting, initiation, steering or adjudication board management. He has experience working with CRO’s, central lab selection and management, CRA and clinical project assistant management, SOP writing and field clinical team activity coordination.
During his role as clinical trial manager, he was involved in the line management of an entire CRA team for heart valves and cardiac rhythm management activities. He was involved in the protocol, study report, monitoring plan validation and the elaboration and management of the vigilance activities for the clinical point of view.
He has extensive experience in representing the core clinical team with various cross functional activity across the clinical affairs department for regulatory, safety, quality and study organization. He also has experience as a compliance safety officer and as a clinical QA advisor (audit, SOP writing, Team training).
Prior to joining VCLS, Emmanuel worked with the Livanova (Sorin Group) as clinical project manager, clinical trial manager and most recently as a senior clinical specialist, where he lead the complete management of international clinical studies. He has also worked with Laboratoire THERAMEX as an international clinical trial coordinator.
Emmanuel is an engineer in biotechnology from the E.S.B.S. (Ecole Supérieure de Biotechnologie de Strasbourg) and earned a Master's degree in molecular and cell biology.
Emmanuel Prades is based in our Paris office.