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Omfattning Heltid
Publicerad 2024-06-14

Clinical Trial Associate fluent German CTA role provides technical support to the clinical trial capabilities team in support of clinical development. The assistant is responsible for activities related to investigator sites readiness, maintenance and close out. The assistant will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.  Job Description Initiate investigator site activities, including collection and submission of regulatory documents. Track and ensure site compliance to effectively drive timelines aligned with company priorities Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out Support TPO and investigator payments as appropriate Manage site account requests Invoice query resolutions Identify, communicate, and resolve issues Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements. Ensure appropriate archiving of documents to meet company record retention policies and regulatory requirements. Ensure inspection readiness through a complete, accurate and readily available Trial Master File Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out Identify, communicate, and resolve issues Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems Leverage previous site / review board engagements to efficiently drive new work Populate internal systems to ensure accuracy of trial / site performance Understand and comply with procurements, legal and financial requirements and procedures Populate Trial Master Files and libraries for future reference Provide feedback and shared learning for continuous improvement Leverage trial prioritization Anticipate and monitor dynamically changing priorities Minimum Qualification Requirements:   A degree or equivalent preferably in a scientific or health related field, Two years clinical research experience or relevant experience preferred Fluent German speaker and fluency in English is essential for this role. Applied knowledge of project management processes and skills Appreciation of / experience in compliance-driven environment Ability to learn and comply with regulatory requirements and internal policies. Effective communication, team work and problem solving skills Very good attention to details and accuracy Self-management and organizational skills Excellent computer skills   Required language: German

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Omfattning Heltid
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