.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.We are looking for a Local Start Up Specialist I / II (LSUS) to join our A-team (hybrid* / remote)! The Local Start-up Specialist (LSUS) 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.This role can be based anywhere in Spain but also out of our office in Madrid!Key Tasks: Track relevant information, data, progress and milestones in CTMS and / or other tracking tools covering assigned Start-Up activities.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' process.Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study.Negotiate within client approved contract and budget templates and negotiation parameters
