Start-Up Associate Ii

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cy6cn

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 GSCM impacting site contracts’ proce

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cy6cn