Clinical Research Manager

5 months ago

Kirkland, Canada Merck Canada inc Full time

Job Description

Chef, Recherche clinique

Ce rôle est principalement responsable de la gestion de bout en bout du rendement et des projets pour les protocoles attribués dans un pays, conformément aux Bonnes pratiques cliniques de la Conférence internationale sur l'harmonisation, aux règlements du pays, aux politiques et procédures de notre entreprise, aux normes de qualité et aux exigences de déclaration des événements indésirables, tant à l'interne qu'à l'externe.

Vos responsabilités principales en tant que Chef, Recherche clinique:
Agir comme point de contact principal pour les protocoles attribués et comme agent de liaison entre les Opérations du pays et l'équipe d'essais cliniques.

**Assurer la gestion de projets pour les études attribuées**: planifier, diriger et suivre de façon proactive l'exécution et le rendement pour les produits livrables/échéanciers/résultats afin répondre aux engagements du pays, de l'analyse de la faisabilité et de la sélection des centres au recrutement, à l'exécution et à la clôture des études.

Gérer le rendement pour les protocoles attribués dans un pays, conformément aux Bonnes pratiques cliniques et Conférence internationale sur l'harmonisation et aux règlements du pays, aux politiques et aux procédures de notre entreprise de même qu'aux normes de qualité et aux exigences de déclaration des événements indésirables, tant à l'interne qu'à l'externe.

Baccalauréat en sciences.

De cinq à six ans d'expérience en recherche clinique.

Minimum d'un an d'expérience en gestion de projets des études cliniques et de la gestion de centre.

Expérience en tant qu'associé(e), Recherche clinique, un atout.

Solide sens de l'organisation avec succès démontrés.

Capacité de prendre des décisions de façon autonome et de superviser d'importantes activités se rapportant à la recherche clinique, conformément aux politiques et aux engagements prédéterminés à l'échelle mondiale et avec le soutien, la direction et la supervision du chef du champ thérapeutique ou du directeur, Recherche clinique.

Solide compréhension de l'environnement réglementaire local.

Solides connaissances dans le domaine scientifique et la recherche clinique (requises).

Solide compréhension de la planification, de la gestion et des outils de mesure des essais cliniques (essentielle); capacité à se concentrer sur plusieurs produits livrables et protocoles simultanément.

Maîtrise du français, à l'oral et à l'écrit.

Conformément à la Stratégie de milieu de travail hybride de notre entreprise, ce poste sera exécuté au moyen d'une combinaison de travail à distance et de travail en personne (siège social de Kirkland) en fonction de la nature du travail à effectuer.

Nous sommes fiers d'être une entreprise qui embrasse la valeur de rassembler des personnes diversifiées, talentueuses et engagées. La façon la plus rapide d'innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collègues à remettre en question avec respect les problèmes de réflexion et d'approche de l'un et de l'autre. Nous sommes un employeur souscrivant au principe de l'égalité d'accès à l'emploi et nous sommes déterminés à

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