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