At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for 0.5 Fte The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit. In this roleyour key tasks will include: * Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)



* Ensure planned dates are reliable and up to date in CTMS departments/study teams * File documents in the (e)TMF for which they are the document owner * Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner * Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level * Provide relevant documents in compliance with local regulation * Support review of technical, pre-clinical and clinical reports for regulatory submissions * Interact with regulatory authorities * Prepare and compile answers for questions raised by the regulatory agencies and submit the answers * Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate * Support Integral Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed * Prepare, compile, submit and maintain ethical requirements and doc

📌 Start-Up Associate Contractor (Madrid)
🏢 Allucent
📍 Madrid