Beschreibung
Clinical Study Manager- 12 Month Contract - GhentI am currently working with an innovative Biotech 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;
- Responsible for leading and guiding and overseeing the CROs 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 MedWatch reports to FDA, EMEA 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 timelines and budget and delivering studies within timelines, 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;
- 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;
- 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