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Monitor de ensaio clínico

João Pessoa
Tata Consultancy Services
Clínico
Anunciada dia 16 abril
Descrição

Come to one of the biggest IT Services companies in the world! Here you can transform your career! Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment. We are looking for Medical Monitor who wants to learn and transform his career. In this role you will: Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe. Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management;
demonstrate ability to incorporate global considerations into decision making Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant). Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical...

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