em<rolling out new treatments leading medical device industry lead engineering cross functional teams launch first product range - Azuqueca de Henares - beBeeClinicalDevelopment

    beBeeClinicalDevelopment
    beBeeClinicalDevelopment Azuqueca de Henares

    hace 1 semana

    Título del trabajo: Clinical Development Leader

    Descripción

    Job Description

    We are seeking a Clinical Development Leader to lead our clinical trials team.

    • The ideal candidate will have experience in planning, designing and supervising the execution of clinical trials contracted to Clinical Research Organizations (CROs).

    In this role, you will be responsible for ensuring that all aspects of the trial are executed within planned timelines and in compliance with current GCP and other applicable requirements.


    The main focus is on pharmacokinetic (PK) and bioequivalence (BE) trials. Multicenter clinical trials and phase II and III trials may also be required with necessary support.


    Assure overall responsibility for plan design execution reporting evaluation results as well as assure conduct of trials in compliance with applicable requirements including but not limited to GCP Design manage clinical trails according to plan ICH EMA FDA etc Participate selection CRO vendors control execute activities ensure that they conducted accordance requirement time quality cost Review documentation before during at end study report etc Coordination internal Chemo related conduct trial eg investigational medication shipment Collaboration health authorities Scientific advice deficiency letters Collaboration departments experts Pharmaceutical Regulatory Pharmacovigilance Project Management define strategies plans projects execution Execute accordingly agreed plans Participation maintenance GCP system through elaboration review SOPs Contribute same Contribution maintained keep following process smooth performing major tasks accomplish objectives successfully.'

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    In short we are looking for a Clinical Development Leader to plan and supervise the execution of clinical trials in compliance with GCP and other applicable requirements. · ...

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Azuqueca de Henares