Clinical Project Manager

il y a 11 heures

Bordeaux, France CEVA Santé Animale Temps plein

Major contributor in the assessment of clinical development plan to support the approval of new pharmaceutical products or product LCM (new indication, geo-extension or defense), the clinical project manager is responsible of clinical plan implementation including determination and confirmation of the appropriate dosage, evaluation and demonstration of the efficacy of the product but also of its tolerance under field condition. The main functions will be: ? Participate in the clinical development plan for new products or their LCM (new indication, addition of target species) in line with the target product profile and responsible of its implementation ? Conduct and coordinate clinical studies (dose determination, dose confirmation, field studies) in compliance with Good clinical practices, international (EMA, FDA?) regulatory guidelines and animal welfare as sponsor representative, including study design, protocol preparation, conduct of animal phase, result interpretation and final study report drafting in collaboration with the monitors, the data manager and the biostatistician ? Play role of Core team member within projects, by providing clinical expertise, strategic planning, risk assessment and support for all clinical activities ? Collaborate constructively and synergistically with other functions (e.g. Innovation, Formulation, Regulatory Affairs, Pre-Clinical, QA?). ? Support regulatory affairs to prepare the MA dossier and to answer questions from regulatory agencies (EMA mainly but also FDA). ? Support Technical/Marketing corporate for product launch/defense with scientific abstracts, presentations, and manuscripts for publication of clinical study data ? Support innovation by conducting proof of concept studies ? Develop specific expertise/medical knowledge and a comprehensive understanding in the therapeutic fields of the project he/she will be involved. ? Develop and manage a network of experts ? Ensure regulatory and scientific literature monitoring The context and the challenge of the position are characterized by a large number of interlocutors, a great diversity of studies, strong regulatory requirements and an international context (Europe, USA, ?). Skills and Competencies: ? Veterinarian or scientific knowledge of veterinary fundamentals (especially in internal medicine for Pets) ? Minimum 5 years' experience in clinical development ? Large knowledge of clinical trial methodology (Good Clinical Practice, evaluation criteria, biostatistics), clinical trial monitoring and European regulation ? Good knowledge in clinical project management and study outsourcing (CROs management) ? Regulatory knowledge in international development of veterinary products (EMA, FDA) ? Proficiency in writing scientific documents ? Communication skills, project management and team spirit are also essential. ? Fluent in oral and written English is mandatory ? Standard practice in oral and written French if possible CDI (Permanent contract) Executive status Envoyer une demande > Send

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