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Madrid - International CRA Trainer / Mentor - Southern Europe

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Madrid - farmacéutica - Manager - Grünenthal

Main duties/responsibilities   Assess the individual Clinical Research Associate (CRA) competencies, skills and general performance during the day-to-day management of a Grünenthal sponsored trial. Initiate appropriate and proportionate measures to correct/improve performance. Verify compliance with the trial protocol, good clinical practice (GCP), (inter)national regulatory requirements and laws and Grünenthal and/or external vendor procedural documents.     Requirements   Educational background & professional experience: University degree or suitable scientific, medical, pharmaceutical education.  Comprehensive understanding of drug development process and detail processes in clinical trials. Demonstrable practical experience as a Clinical Research Associate for at least 5 years; additional Quality Assurance and/or Clinical Study Manager experience is beneficial. Comprehensive knowledge of ICH-GCP E6. Thorough understanding of global and local regulations and guidelines. Preferably experience in personal coaching or mentoring.   Personal skills and motivations: Fluent in verbal and written English. Willing to travel frequently  (at least 50% outside Iberia is anticipated). Good working knowledge of Microsoft Office applications. Advanced verbal and written communication skills ...


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