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.
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' proc
📌 Start-up associate ii (Lazio)
🏢 Allucent
📍 Lazio
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