Clinical Trial Assistant

For our client, expert in medical devices, we are looking for a Clinical Trial Assistant

As a Clinical Trial Assistant, you'll be at the forefront of clinical research excellence, ensuring the success of clinical studies. Your responsibilities encompass a wide range of critical functions:

• Document Management: Responsible for meticulous collection, review, and organization of information and documents in strict compliance with guidelines, regulations, and procedures.
• Collaboration: Establish and maintain strong collaborative relationships with investigation site personnel and Clinical Research Associates (CRAs) to ensure the completeness of the Trial Master File.
• Sponsor Support: Play a pivotal role in setting up the Trial Master File (TMF)/electronic TMF for the Sponsor, aligning with the cross-functional team on the expected study documents.
• Investigator Site File (ISF): Prepare the ISF during the activation phase of clinical studies, ensuring all essential documentation is in place.
• Clinical Materials: Provide essential support to the clinical team by assisting in the preparation of materials for clinical trials, including Investigational plans, Investigator’s brochures, and patient information documents.
• Regulatory Compliance: Prepare and submit files for Ethical Committee, Competent Authority, and other regulatory bodies when required.
• Meeting Coordination: Assist in organizing Investigators, Steering, and Data Monitoring Committee (DMC) Meetings, managing bookings, reservations, and providing logistical support.
• Clinical Event Committee (CEC): Support the preparation of CEC files and events as needed for CEC meetings.
• Quality Assurance: Review applicable clinical study plans and create or support the development of a Trial Master File plan for each clinical study.
• Quality Control: Initiate and perform quality controls of study documentation in line with Standard Operating Procedures (SOPs) and project-related plans.
• Inspection Readiness: Ensure that study documentation is inspection-ready, focusing on the essential documents as per ISO14155 and Good Clinical Practice (GCP) guidelines.
• SOP Review: Review SOPs and recommend updates when necessary.
• Archiving: Perform document archiving followingprocedures and current regulatory standards.

• Prior experience in clinical trial administration is essential.
• Strong desire to grow within the position, with a stable, long-term commitment to the administrative team.
• Proficiency in Microsoft Word, Excel, and Teams, with a basic understanding of PowerPoint.
• Good knowledge of the DIA Reference Model, a recognized structure for document filing in the industry.
• Ability to work with electronic Trial Master Files (eTMF), including Veeva or similar systems.
• Capacity to work effectively with project managers, CRAs, safety personnel, data management, statisticians, and other stakeholders in terms of documentation.
• Fluent in Dutch and English
• A keen eye for detail to ensure the precision and accuracy of documents.
• Strong dedication to fostering a team spirit and contributing to a collaborative work environment.

Our client can offer more than just a job. It's an opportunity to make a difference, contribute to society, and be a part of their passionate and high-performing team.