Idéalement situé en Sud Vendée sur la commune de Fontenay le Comte, le circuit propose des essais et roulages auto/moto/karting, de la recherche et du développement, des essais industriels ainsi que des séminaires et incentives pour tous les groupes et professionnels. Le circuit dispose de deux pistes Asphalte, l'une de 2400m, l'autre de 1083m, d'un terrain d'évolution 4x4, d'un paddock de 8000m2 et de différents espaces réceptifs. Piste de karting électrique Indoor.

Développement de la marque employeur et mise en avant des métiers et compétences de Niort Agglo.

► Organisation de la partie clinique du projet, planification des livrables, reporting hebdomadaire ► Encadrement d’une équipe allant jusqu’à 20 personnes dans une dizaine de pays en Europe ► Collaboration avec les services transverses (réglementaire, gestion des données, assurance qualité, pharmacovigilance,…)► Formation régulière des ARCs par visioconférence ou en présentiel► Création des documents, procédures et outils nécessaires au bon fonctionnement du projet ► Communication: animation régulière de réunion avec les équipes en interne, le laboratoire pharmaceutique et les médecins, création de Newsletter, présentations lors de meeting de lancement d’étude► Organisation logistique : coordination avec les différents prestataires impliqués (agence d’événementiel, fournisseurs d’équipement, transport des patients,…) ► Gestion quotidienne des aléas et difficultés inhérents au projet ► Contribution aux appels d’offre

Accountable for the delivery of all clinical monitoring aspects (timelines, budget, data/reports quality) in compliance with all applicable regulations and Sponsor requirements - Direct reporting/communication with Sponsor and local affiliates - Study Resource management - Study start-up activities (kick-off meeting, regulatory submissions, CTMS set-up) - Sponsor audit/Inspections - Database lock After 2008, CTL on 2 European studies (Phase IIIb) in Oncology (6/8 countries, 45/47 sites respectively) from a 6 studies Program - Referent CTL at Program levelBefore 2008 European CTL - International study in Ophthalmology (12 countries, 24 sites, 189 patients)Achievement: High satisfaction from Kendle management and Sponsor (timelines, proactivity, Sponsor procedures compliance)

- Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations- Provides clinical and technical support for CRA I and administrative staff- Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating procedures (PSOPs)- May assume the role of a Lead CRA on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study project managerCo-lead CRA activities in European study in Cardiology (40 sites/7 countries): LCRA support & back-up (monitoring report review, direction and guidance to study team, coordination of all monitoring activities and communication of the status of these activities to Project Leader and Sponsor) Gained Skills* Team management* Regulatory aspects* Report review process

Acquired by Inveresk Research in July 2003; Completion of project activities with monitoring functions of Phase II-IV studies: site visits conduct (pre-study visit, site initiation visit, monitoring visit & closure visit), management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and SOPs - Regulatory submissions (to French Ethics Committee and Competent Authority) - SAEs reporting managementGained Skills* Source data verification * Site Management

Epidemiological national study - Dyslipaemia- Start-up activities- Investigators' database creation and study documents tracking- Call-center activity- Data entry- Monitoring visits and monitoring reports- Management of Investigator payment

- Follow-up and Management of a phase III clinical trials in Dermatology- Monitoring visits and Site Closure visits (visit reports writting)- Management and return of IMPs- Queries Management- Preparation and participation to blind review meeting- Study material inventory