Freelance Clinical Study Manager

Job type:
on-site
Start:
11/2019
Duration:
12 Months
From:
Phaidon International
Place:
Ghent
Date:
10/25/2019
Country:
flag_no Belgium
project ID:
1840264

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Clinical Study Manager- 12 Month Contract - Ghent

I 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