Job Description

Study Start-Up Specialist & Country Study Specialist | Anderlecht

Belgium Pharmaceuticals
Posted by Sarah on 22/03/2019

A new Study Start-Up Specialist & Country Study Specialist opportunity !


You will be responsible for the preparation of the participating 'sites' in a new study and be active as the the link between Brussels / Copenhagen.

What your day looks like:

  • Execute all start-up activities prior to site activation on assigned studies
  • Maintain and analyze study start-up data
  • To track and drive site activations and trial amendments submissions
  • Provide guidance on regulatory/ethics requirements
  • Collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws
  • Support drug label preparation and approval
  • Contracts negotiation
  • Prepares ongoing submissions, amendments and periodic notifications

 

What your profile looks like:

  • University Degree or equivalent, preferably in a medical/science-related field
  • Previous experience as CRA / Lead CRA is a must
  • Understanding of clinical trials and experience in managing projects
  • Knowledge of ICH-GCP, as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials
  • Fluent in English, Dutch and French

 

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