- Document Management: Responsible for meticulous collection, review, and organization of information and documents in strict compliance with guidelines, regulations, and Terumo 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 following Terumo procedures 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 English, with proficiency in additional languages as a valuable asset.
- 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.
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Clinical Trial Assistant - Leuven, België - Terumo
Beschrijving
Job Summary
Are you ready to make a significant impact in the world of healthcare? Join our team as a Clinical Trial Assistant and play a pivotal role in advancing medical research. Reporting to the Clinical Operations Manager, Irene Barriocanal, you will be an essential part of our dynamic European Medical and Clinical Division at the EMEA HQ.
Job Responsibilities
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:
Clinical Trial Administration Activities:
In this role, you'll also be expected to act as a company representative , consistently upholding our values and standards. Additionally, you should be prepared to embrace versatility by willingly taking on extra responsibilities as needed, actively contributing to department-wide tasks, and participating in projects or initiatives aimed at enhancing process optimization. It's imperative that you operate in alignment with Terumo's core values , ensuring your actions and decisions reflect our commitment to excellence and integrity.
Profile Description
Offer
At Terumo, we believe in offering more than just a job. It's an opportunity to make a difference, contribute to society, and be a part of our passionate and high-performing team.
Rewards That Match Your Dedication: We offer a competitive salary and benefits package that sets the benchmark for rewarding your commitment.
Join a Passionate Team: Become a valued member of our passionate and high-performing team where everyone is treated with respect. We are dedicated to creating a diverse, equal, and inclusive work environment.
Invest in Your Development: At Terumo, we invest in our associates by providing a wide range of development opportunities to help you grow both personally and professionally.
Work-Life Flexibility: Experience a hybrid way of working that balances office and home-based work to the fullest.
Connect with Us: During the recruitment process, you'll have the opportunity to engage in meaningful conversations with the hiring manager and other enthusiastic Terumo associates.
Ready to Make a Difference? Are you curious and ready to explore the possibilities at Terumo? Watch our or visit our to learn more. Your journey to a fulfilling career starts here.
