Lead Clinical Research Associate (H/F)
Stryker
Pourquoi rejoindre Stryker?
Vous cherchez un endroit qui valorise vos talents uniques ? Découvrez la culture primée de Stryker.
Rejoignez une fonction clé au cœur de la recherche clinique internationale. En tant que Lead Clinical Research Associate , vous contribuerez directement à la qualité, à la conformité et à la performance des études cliniques, en collaboration étroite avec les équipes Program Management et Study Operations. Vous interviendrez sur l’ensemble du cycle de vie des études, de l’ouverture des centres jusqu’à leur clôture, avec un fort niveau d’autonomie et d’impact. Ce poste s’adresse à un profil expérimenté souhaitant évoluer dans un environnement exigeant, collaboratif et à forte dimension internationale.
Lieu de résidence : Basé(e) en France, idéalement à proximité d’un aéroport international afin de faciliter les déplacements.
Déplacements fréquents en France et à l’étranger (70%).
Ce que vous ferez :
Piloter les activités de suivi des centres investigateurs tout au long du cycle de vie des études, de l’initiation à la clôture.
Encadrer, orienter et accompagner les CRA (Clinical Research Associates) afin de garantir un niveau élevé de qualité, de conformité et de performance opérationnelle.
Définir, déployer et maintenir les plans de monitoring clinique ainsi que les outils et documents associés à l’étude.
Coordonner les activités cliniques avec les équipes projets, notamment sur les sujets de recrutement patients, d’activation des centres et de stratégie régionale de monitoring.
Contribuer à la création, la revue et l’amélioration des documents d’étude, procédures et supports de formation nécessaires à la bonne conduite des essais.
Assurer le suivi de la qualité des données sites, identifier les écarts, piloter les plans d’actions correctifs et soutenir l’analyse des tendances.
Réaliser et/ou superviser les visites cliniques (qualification, initiation, monitoring, clôture) ainsi que les co-visites avec les CRA.
Développer des relations de travail solides avec les investigateurs, les KOL, les centres et les partenaires externes, tout en contribuant à la performance des CRO.
Ce dont vous avez besoin :
Diplôme de niveau Bac+3 minimum (Licence/Bachelor) requis, ou diplôme supérieur en soins infirmiers ; un niveau d’études supérieur est apprécié.
Certification en recherche clinique souhaitée.
Expérience confirmée de 6 ans minimum en tant qu’Attaché(e) de Recherche Clinique (ARC/CRA) ou dans un rôle de gestion opérationnelle d’essais cliniques.
Expérience préalable en tant que Lead CRA (ou équivalent) ou en gestion de projet, avec coordination d’activités cliniques complexes.
Une expérience en neurovasculaire ou en cardiologie (EVT) constitue un réel avantage.
Capacité démontrée à travailler en autonomie, à coordonner des parties prenantes multiples et à piloter la qualité dans un environnement international.
Excellente maîtrise du français et de l’anglais ; la maîtrise d’une troisième langue est un atout.
Excellentes compétences relationnelles et de communication, avec une capacité à collaborer efficacement dans des environnements multiculturels et multidisciplinaires.
Ce que nous offrons :
Hiérarchies horizontales et responsabilité. Grâce à des hiérarchies horizontales, nous renforçons l'initiative et la volonté de nos employés d'assumer des tâches à responsabilité.
Nous développons les talents. Chez Stryker, nous offrons à nos employés un excellent développement de carrière personnel et interne, avec la possibilité d'évoluer verticalement et latéralement.
Esprit d'équipe et engagement. Nous créons des équipes engagées et inclusives qui encouragent les collègues à partager leurs points de vue et opinions divers.
Salaire compétitif. Chez nous, vous recevrez un salaire compétitif en rapport avec votre travail.
Reconnaissance de vos performances. Dans notre entreprise, les performances individuelles et interfonctionnelles exceptionnelles sont récompensées. Les idées, projets ou autres réalisations exceptionnelles peuvent être soumis à divers prix au niveau local et mondial.
Nous sommes fiers de vous offrir un ensemble de récompenses qui comprend des primes, des soins de santé, des prestations d'assurance, des programmes de retraite, des programmes de bien-être, ainsi que des récompenses pour services rendus et performances - sans oublier diverses activités sociales et récréatives, qui sont toutes spécifiques à chaque site.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.- A leading health care organization in Hartford, Connecticut, seeks a Clinical Research Associate to manage clinical trial activities, supervise staff, and ensure compliance with research protocols. The ideal candidate will have at least a Bachelor's degree in a relevant...Suggested
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