DescriptionAt 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 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 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 teamsFile documents in the (e)TMF for which they are the document ownerAssist other Study Start-up team members with filing documents in the (e)TMF for which they are document ownerAssist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local levelProvide relevant documents in compliance with local regulationSupport review of technical, pre-clinical and clinical reports for regulatory submissionsInteract with regulatory authoritiesPrepare and compile answers for questions raised by the regulatory agencies and submit the answersRegularly check for updates on regulations, guidelines and procedures.
Ensure these updates are communicated and circulated as appropriateSupport Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as neededPrepare, compile, submit and maintain ethical requirements and documentation required by IEC

Start-Up Associate II

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