Senior Clinical Data Manager

<h3>📋 Description</h3> • Coordinates CDM process initiatives, including project management, process definition, implementation, change management, and training plans. • Provides regular communications to CDM staff on CDM Operation activities (e.g. process alerts, training updates, changes, and initiative announcements). • Supports the development and revision of CDM processes for both outsourced and in-house studies. • May act as a point of contact and support for CDM staff on key process topics related to data management activities during study startup, conduct, and close out, and working in CDM systems. • Collaborates with key stakeholders and CDM Operations to support CDM team on setup and management of EDC local lab activities. • Supports the maintenance of the CDM Subject Matter Expert (SME) network for process topics, facilitating timely updates and discussions. • Supports the maintenance and enhancements of departmental Sharepoint sites and trackers, as needed. • Assists in determining role assignment for the Learning Management System (LMS) and associated learning plans. • Supports CDM staff with Quality Assurance related activities such as inspection & audit responses, in collaboration with the CDM Operations Compliance & Quality team. <h3>🎯 Requirements</h3> • Preferred 6 plus years or equivalent experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function. • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. • Proven track record of strong project management skills and experience managing data management activities for large drug development programs. • Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, Vaccines and/or vaccine. • Preferred experience with FDA, EMA or other regulatory inspections of sponsor or CROs • Ability to handle multiple projects simultaneously. • Strong knowledge of data management best practices & technologies as applied to clinical trials. • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function. • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. • Au moins six ans d'expérience, ou équivalent, en gestion de données et/ou en processus de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données. • Excellente compréhension des documents d'essais cliniques (protocoles, plans d'analyse statistique, CRF, rapports d'étude) et des processus. • Excellentes compétences avérées en gestion de projet et expérience de la gestion des activités de gestion des données pour de grands programmes de développement de médicaments. • Connaissance des BPC, des directives réglementaires et de l'ICH applicables à la gestion des données cliniques ;Expérience clinique souhaitée dans un ou plusieurs des domaines thérapeutiques suivants : thérapie cellulaire, oncologie, gastro-entéologie, neurosciences, PDT, maladies rares, vaccins. • Expérience souhaitée avec la FDA, l'EMA ou d'autres inspections réglementaires de promoteurs ou de CRO. • Capacité à gérer plusieurs projets simultanément. • Excellente connaissance des meilleures pratiques et technologies de gestion des données appliquées aux essais cliniques. • Connaissance approfondie du processus global de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données. • Connaissance approfondie des réglementations FDA et ICH et des normes industrielles applicables au processus de saisie et de gestion des données. <h3>🏖️ Benefits</h3> • Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others