Clinical Trial Manager

hace 1 semana


Barcelona, España Clínic A tiempo completo

Private Foundation Món Clínic BarcelonaWe are a private, newly created, and non-profit Foundation, linked to the Hospital Clinic de Barcelona, whose mission is to strengthen people's health and improve the quality of life of citizens. To respond to our founding goals, we have a CRO (Barcelona Coordinating Center, BCCC) for conducting clinical studies, initiated by the pharmaceutical and medical device industry or by researchers, offering a comprehensive portfolio of services to meet the needs of our customers.What We Are Looking for:We are seeking a Clinical Trial Manager, who will act as Clinical Trial Monitoring Coordinator. He/she will report to the Head of Monitoring and will coordinate the internal and external Clinical Research Associates (CRA) assigned to the clinical studies.Responsibilities:The incorporated person will be responsible for:§ Clinical Trials Monitoring Coordination.§ Elaboration of monitoring plans adapted to the characteristics of the study and following the internal procedures on Risk Based Monitoring.§ Organization of the team of CRAs to respond to the needs of the different projects.§ Carrying out initial, follow-up and closing visits to some sites and elaboration of monitoring reports.§ Monitoring subject recruitment.§ Collaboration with Regulatory in submitting relevant requested documents.§ Collaboration with Project Management and, among other things, preparing together with the Project Managers specific study documents (Monitoring Plan, Pharmacy Manual, Laboratory Manual, etc).§ Collaboration with Data Management.§ Contribute to monitoring of serious adverse events.§ Sites feasibility: review of questionnaires, and review of Pre-Study Site Visits (PSSVs) reports.§ Defining the documentation package required for sites' initiation and activation.§ Preparing periodic sites follow up reports (as set in the Project Management Plan: contracts status, activation, recruitment, and withdrawal rates, etc), to be reviewed by the CPM and sent to the Sponsor.§ Mentoring and applicable training to junior and trainee CRAs.§ Collaborate with QA Department, as requested.Requirements:§ University degree in Life Sciences§ More than 4 years of experience, managing clinical trials, observational studies, etc.Valuable:§ Postgraduate training in Clinical Trials.§ Experience in managing Monitors teams.Working conditions:§ Full time position§ Offices located in Barcelona§ Salary according to experience§ Starting date of the contract: June 2024If you are interested in this offer, please send your CV to the following email: ******#J-18808-Ljbffr



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