Clinical Project Manager - Mexico City, México - Novartis

    Novartis
    Novartis Mexico City, México

    hace 1 mes

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    De jornada completa
    Descripción
    About the role
    :

    Novartis Corporate Center Mexico City is one of six strategically located corporate centers established by Novartis globally. It brings together expert capabilities and talent across functionalities, that drives the business forward.

    It is home to 1000+ associates who work to deliver on the Novartis purpose of re imagining medicine to improve and extend people's lives.

    Your key responsibilities


    • Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
    • Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
    • May identify new sites for clinical trials; analyze capability & make recommendation for trial inclusion. -Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
    • Responsible for education, implementation & compliance to standards (SOPs) & best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
    • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
    • Distribution of marketing samples (where applicable)
    • Responsible for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations etc.) executed by CONEXTS on behalf of Novartis Organizations, under the lead of Senior Clinical Project Manager (Sr. CPM) (where applicable).
    • Work with the Sr. CPM (where applicable), Clinical Operations Specialist (COS) and Team leading the planning and implementation of all operational aspects of assigned clinical studies from concept to reporting/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). Responsible for ongoing and effective collaboration with customer, other Line Functions and third-party vendors. Track performance and quality aspect.