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Clinical Quality Manager
4 months ago
As a CQM. Principal Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Project Management & Execution:Manages and drives all aspects of document development, revision, retirement, according to the Procedure section of this Charter, ensuring documents are written in alignment with sponsor procedures and quality standards.Ensures Document Owner is informed of the process to develop, revise, or retire a controlled document.Supports Document Owner with authoring. May author new documents upon request and as appropriate. Manages and drives collaborative review, ensuring relevant functional area representation and drives resolution of edits/comments in collaboration with relevant stakeholders. Ensures completion of Learning Needs Assessment and Training Curriculum Impact Assessment.Leads and drives Implementation planning in close collaboration with Document Owner and other relevant stakeholders. Ensures final endorsement of document(s) prior to coordinating approval workflows in the Document Management System (DMS). Acts as QMS Action Item Owner for CAPA Action Items requiring a controlled document revision.Acts as QMS Planned Deviation Owner for Planned Deviations identified as part of implementation planning.Responsabilités :Gestion et exécution de projetsGère et pilote tous les aspects du développement, de la révision et du retrait des documents, conformément à la section « Procédures » de la présente charte, en veillant à la rédaction de documents en conformité avec les procédures et les normes de qualité du commanditaire.S’assure que le propriétaire du document est informé du processus d’élaboration, de révision ou de retrait d’un document contrôlé.Aide le propriétaire du document à créer des documents. Peut créer de nouveaux documents à la demande et selon les besoins.Gère et pilote l’examen collaboratif, en veillant à la représentation des domaines fonctionnels concernés et à la résolution des modifications/commentaires en collaboration avec les parties prenantes concernées.Assure la réalisation de l’évaluation des besoins d’apprentissage et de l’évaluation de l’impact du programme de formationDirige et pilote la planification de la mise en œuvre en étroite collaboration avec le propriétaire du document et les autres parties prenantes concernées.Assure l’approbation finale du ou des documents avant la coordination des processus d’approbation dans le système de gestion des documents (SGD).Agit en tant que propriétaire de l’élément d’action du SGQ (système de gestion de la qualité) pour les éléments d’actions correctives et préventives nécessitant une révision du document contrôlé.Agit en tant que propriétaire des déviations planifiées du SGQ pour les déviations planifiées identifiées dans le cadre de la planification de la mise en œuvre.Requirements:Bachelor’s degree in a life sciences discipline highly preferredTypically requires 8-10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industryIt is essential that this person wants to use their knowledge and experience to improve the way Global Clinical Operations (GCO) runs clinical trials. This person will be leading meetings and facilitating conversations and completion of deliverables with Subject Matter Experts. Sponsor/CRO GCP experience required (experience in a Clinical Project Manager role is ideal)Strong operational understanding of Clinical Trials and GCPProject Management experience is a mustStrong interest and understanding of Process/Controlled Document Management – this can be trained for the right personExemplary organization, communication, and facilitation skillsExemplary QC skillsCompétences :Diplôme de baccalauréat dans une discipline des sciences biologiques de préférenceEn général, 5 à 7 ans d’expérience, ou une combinaison équivalente d’études et d’expérience, dans l’industrie biopharmaceutique est requiseIl est essentiel que cette personne souhaite utiliser ses connaissances et son expérience en vue d’améliorer la manière dont les essais cliniques sont gérés par les Opérations cliniques mondiales (OCM). .Cette personne dirigera des réunions et facilitera les conversations et la réalisation des produits livrables avec les experts en la matière.Expérience requise en matière de BPC pour les commanditaires et les ORC (une expérience dans un rôle de gestionnaire de projets clinique est idéale)Solide compréhension opérationnelle des essais cliniques et des BPCUne expérience en gestion de projet est indispensableIntérêt marqué et compréhension du processus et de la gestion des documents contrôlés – une formation peut être dispensée à la personne concernéeCompétences exemplaires en matière d’organisation, de communication et de facilitationCompétences exemplaires en matière de CQM
