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  • Location

    Utrecht, Gemeente Utrecht, Utrecht

  • Job title:

    Clinical Trial Coordinator

  • Sector:

    Biotechnology, Pharmaceutical

  • Job ref:

    46439

  • Start Date:

    2021-07-07

The Company 
Our client is a clinical-stage biopharmaceutical company located in Utrecht, The Netherlands.

Role Description

As Clinical Trial Coordinator you will support a Phase III pivotal study to ensure regulatory approval from the US Federal Drug Association (FDA) and European Medicines Agency (EMA). You will play a pivotal role in bringing to market this potential life-saving medical treatment. You will have the opportunity to work with a collaborative and successful team to support our Clinical Trial Management and Project Management teams with operational activities.


Responsibilities 
  • Provide technical support to the  project team
  • Coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the project manager/VP of Clinical Operations
  • Reviews regulatory documents for proper content
  • Coordinates teleconferences and creates meeting agendas
  • Distribution of meeting minutes and finalization of minutes
  • Create/ Set-up Trial Master File
  • Maintain and Track clinical study documentation under GDP

Requirements
  • Proficient English language skills
  • Experience with Phase III clinical studies (Phase II experience will also be considered)
  • Strong interpersonal skills and high attention for detail, with ability to handle multiple tasks efficiently and effectively
  • Good communication skills with ability to work in small team environment
  • Previous administration experience in clinical research
  • Ability to analyze documents, project specific data and systems for accuracy and efficiency

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804