France
13 years of experience in medical affairs and clinical operations, including 11 as project and program manager in an international context and 3 years abroad (US & Canada). Communicative with excellent interpersonal skills, strong attention to detail, very organized and responsive, enthusiastic and enjoys taking initiative and solving tough problems. I will be pleased to put my skills and my energy in a dynamic company that would enable me to evolve as a Project Manager.
Global Clinical Study Manager for Sanofi Consumer Healthcare (CHC) - Management of clinical trials in allergy and digestive areas
-> Drive operational excellence for the execution of the Medical activities. - Define and align the strategic plan in collaboration with global medical team members. - Drive planification and ensure implementation of Brand Medical Plan - execution of clinical and medical activities. - Actively manage medical brand program Budget. - Prioritization of activities, studies, resources, and budget. - Coordination of multidisciplinary, internal and external teams. - Contribution to cross-functional projects for simplification, optimization and transformation of processes.
Clinical Trial Manager for phase 1 (combined phase 1-2a) study in hypoparathyroidism - Rare Disease o CROs selection process o Study development, protocol and study documentation review o Feasibility study preparation, study follow-up o Regulatory submission oversight o CROs oversight, contract negotiation, budget monitoring o Recruitment oversight o IMP and ancillaries management with the CMO: identification of the needs, packaging and labelling strategy oversight, supply coordination, IMP instructions manual creation. o Samples logistics oversight: distribution to vendors, analysis logistics. o Management of the Scientific Review Committee for data review after each cohort o Data management and data presentation for internal and external communication, abstract and posters o Weekly reporting
ISS Program Manager - Rare Disease Project Manager for over 100 Investigator Sponsored Sudies (ISS) conducted for the following Rare Disease: * Fabry Disease - Fabrazyme * Mucopolysaccharidosis type I (MPS I) - Aldurazyme * and X-LSD (Lysosomal Storage Disorders) studies
International phase III study - 57 countries / 18000 patients * Oversight of a part of South Europe Region : 5 countries managed by a CRO in South Europe - Global supervision of study activities in these 5 countries - CRO supervision : budget, SOW and specific documentation updates, trainings, etc. * Participation to the data management activity oversight : main contact for DRSL and Open CDISC Report activities, participation in DVP updates. * Pre-Approval Inspection preparation : Main contact for FDA1572 Forms/CV, FDF, IPCC and FRD List Therapeutic area: Metabolism : Cholesterol and cardiovascular events
Responsible for all aspects of study site monitoring (including: site qualification, pre-study and initiation visits, monitoring and close-out visits) for several clinical studies, phases III and IV in various therapeutic areas. Dermato-oncology, Gynecology, Pulmonary disease, Endocrinology, Vaccine, Medical Devices
Conducting an international subcontracted phase III study -> Follow-up of Russian, south African and Dutch sites * Study management activities: - Project management: coordination with the CRO and providers, supervision of study activities. Implementation of specific trackers. Invoices and IP deviations tracking. Participation in the weekly update of DM status for reports to the project leader. - Supervision of recruitment: daily verification of recruitment status and updating of metrics, monitoring of patients’ screen failure reasons, participation in the implementation of patient recruitment strategy in order to respect study timelines. - Other activities: Pre-Approval Inspection preparation. Main contact for TMF follow-up for the 4 studies of the program. Participation in the implementation of specific BO reports for subcontracted studies. Participation in a DRS meeting. Therapeutic area: Metabolism, Cholesterol