Overview
As a Clinical Trial Assistant you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs.
We are currently looking for a Clinical Trial Assistant to join one of our sponsor-dedicated teams in Puteaux (3 days office based).
Responsibilities
The Clinical Trial Assistant assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. As a Clinical Trial Assistant you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients’ lives.
Key responsibilities include:
- Trial Master File (TMF) creation and management
- Co-ordinate entry and maintain local data into study management systems including setting up new studies
- Ensure collection, review, track and provision of appropriate clinical documents to support regulatory submission
- Track and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders and Site Initiation presentations/materials
- Process, reconcile, distribute and track essential documents and submit them to local archive in compliance with SOPs
- Complete tracking documentation as applicable including but not limited to spreadsheets, study and contract tracker
- Prepare and review site communication documents
- Set-up/maintain courier accounts and organize shipments
Qualifications
You will need:
- A first stable experience as a CTA or ARC investigateur
- Excellent organization skills
- Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business
- Strong IT skills
- Strong communication with the ability to multitask and work effectively under pressure
- Fluency in French and professional proficiency in English
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