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Research Lead


About the job We are looking for a Clinical Research Manager/Associate To design, coordinate, monitor, and report independently clinical field studies that will support the regulatory approval of new companion animal and livestock products. These studies must be conducted in compliance with the requirements of Good Clinical Practice (GCP). Main tasks The Clinical Research Manager/Associate acts primarily as clinical study team leader (CSTL) and specifically has the following tasks and responsibilities: · Design and organization of clinical studies that meet scientific and regulatory requirements. This includes the setting of objectives, budgetary aspects, resources, timelines and the study protocol. · Prepare the Study Protocol. · Select the Investigators and laboratories for the study. · Apply in time for the necessary study licenses. · Train the study team, as appropriate, in the Study protocol. · Plan and coordinate the monitoring and data management activities of each study. · Ensure that the study is conducted according to legal requirements, VICH GCP and the applicable internal policies and procedures. · Prepare the Final Study Report. · Maintain contact with the all stakeholders (project leader, Regulatory Affairs, Quality Assurance etc.) and keeps them informed of the study progress. Qualifications · Masters degree in one of the life sciences, DVM preferred. · Good written and oral command of English and Dutch · At least 2 years of experience in clinical research or equivalent. · Demonstrated ability in scientific writing This is a temporary position, more information will be provided upon application

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