Description
Clinical Study Manager 12 Month Contract - GhentI am currently working with an innovative Bio tech company based in Ghent that are looking for a Clinical Study Manager for a 12-month project.
The project is in phase III (Oncology) and deals with Auto-Immune antibodies.
Responsibilities;
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Responsible for leading and guiding and overseeing the CR-Os and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan -
Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of Med-Watch reports to FDA, EM-EA and other applicable regulatory authorities -
Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative -
Preparing of study time lines and budget and delivering studies within time lines, scope and budget, aligned with the clinical development plan -
Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager, Head of Clinical Operations or Senior Management, if needed
Requirements;
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5 years Experience within Clinical Operations -
Ideally you will have experience or an understanding and Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study -
Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases) .
Contractual Information;
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12 Month Contract -
Based in Ghent -
3 days on site -
Soon as possible start
If you are interested in the position of Clinical Study Manager in Ghent please follow the appropriate links. Alternatively, if you are a LinkedIn user, please feel free to reach out to me directly at EPM Scientific and search for Stephen O'Mahony