Start-Up Associate Ii

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8gkvgc

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. In this role your 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 IEC/IRB for clinical trials at local level * Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation * Interact with IEC/IRB * Prepare and compile answers for questions raised by the IEC/IRB and submit the answers * Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate * Assist in adapting country SIS/ISF to site-specific requirements * Provide country specific requirements to

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8gkvgc