Job SummaryAs Clinical Trial Assistant (CTA), you will support the planning, execution, and documentation of one to two clinical studies simultaneously. By maintaining accurate, compliant and audit-ready documentation using digital systems such as CTMS and eTMF, you contribute to the smooth and efficient operation of the EMCD. Job Responsibilities Manage study documentation: Collect, review, and file essential documents in line with regulations, guidelines, and Terumo Europe SOPsMaintain TMF/eTMF accuracy: Set up, update, and ensure completeness of the Trial Master File by collaborating with study teams and sitesPrepare study materials: Support the creation of Investigator Site Files, Clinical Investigational Plans, brochures, and patient information sheetsCoordinate submissions: Assist with preparing and filing documentation for Ethics Committees, Competent Authorities, and other regulatory bodiesOrganize study meetings: Provide logistical and documentation support for investigator, steering committee, DMC (Data Monitoring Committee), and CEC (Clinical Event Committee) meetingsEnsure compliance: Conduct quality checks and maintain inspection readiness in line with MDR, ISO 14155, ICH-GCP, GDPR, and local requirementsSupport digital systems: Guide team members on CTMS/eTMF best practices, ensure timely data entry, and troubleshoot system issuesContribute to process improvement: Collaborate on SOP reviews, system enhancements, and cross-functional initiatives to optimize workflowsArchive study records: Perform archiving activities in compliance with Terumo Europe SOPs and regulatory standardsProfile Description As a Clinical Trial Assistant at Terumo Europe, you will play an essential role in supporting the execution and documentation of clinical studies within a highly regulated, international environment. This position is ideal for someone who thrives on precision, organization, and proactive collaboration, and who takes pride in keeping processes running smoothly behind the scenes, combining strong administrative skills with a genuine interest in clinical research. Additionally, you feel comfortable working independently but know when to reach out for clarification or action, whether that means asking critical questions, following up with a site, or coordinating with colleagues. Your structured approach and attention to detail help ensure all study documentation is accurate, complete and compliant. Futhermore, you bring: A background in medical administration or clinical research supportKnowledge of MDR, ISO-14155, GDPR and ICH-GCP regulations; comfortable in a strictly regulated, SOP-driven environment Tech-savviness and a digital mindset, proficiency in Microsoft Office and CTMS/eTMF software such as Veeva Vault, Medidata or OracleExcellent communication skills; fluency in English, with French and/or Dutch as an advantageOffer At Terumo Europe, we believe in offering more than a job. It's an opportunity to make a difference, contribute to society through healthcare, and be 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 recognizing your commitment. Join a passionate team: Become a valued member of our collaborative team where everyone is treated with respect. We are dedicated to fostering a diverse, equitable and inclusive work environment. Invest in your development: 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 Europe associates.