At AllucentTM, 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 II (SUA II) to join our A-team (hybrid*/remote) in Italy 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 Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
Prepare, compile, submit and maintain ethical requirements and documentation required by IE
📌 Start-Up Associate II (Milano)
🏢 Altro
📍 Milano