I manage all aspects of the medical writing processes for document development including, quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions of regulatory documents.

Design and write the protocol and other clinical study documents in compliance with quality and GCP- Preparation and follow-up of regulatory submissions- Definition and updating of the study schedule- Management of the various stakeholders and service providers- Study follow-up: supervision of operational teams, validation of monitoring reports - Organization and facilitation of meetings related to the study- Reporting on the progress of the project to the various parties involved- Budgetary and financial follow-up- Participation in the drafting and updating of procedures (SOP) and quality documents dedicated to the management of clinical studies- Writing of the final report

Elaboration, implementation and coordination of the clinical trials with health professionals and scientists, ensuring compliance with regulations.Scientific/medical expertise in the field of research

Administrative and financial assistant for an academic research unit.Overall management of the structure: budget, research contracts, management of administrative staff and purchases required to carry out clinical studies.Implementation of the purchasing policy and process manager in the context of ISO 9001/ NF S96-900 certification.Member of the budget evaluation office for academic clinical studies.

Development of clinical trial protocols with the clinical project manager.Production of documents necessary for investigators: study brochure, inclusion and exclusion criteria, checklists, etc.Presentation of the study documents, reminding the inclusion/exclusion criteriaConducting pre-selection, initiation and closure visitsLogistics for investigating centers (products, biological samples, medical devices...).