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Madrid - International CRA Trainer/Mentor | Accompanied Site Visit Specialist - Southern Europe -

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Madrid - farmacéutica - Manager - Grünenthal

  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.      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.   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 and focused mind-set.  ...


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