Descripción de la oferta
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.¿Tiene las habilidades necesarias para este puesto? Lea todos los detalles a continuación y presente su candidatura hoy mismo.We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for 0.5 Fte! 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 roleyour 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/IRB for clinical trials at local levelAssist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislationInteract with IEC/IRBPrepare and compile answers for questions raised by the IEC/IRB and submit the answersRegularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriateAssist in adapting country SIS/ISF to site-specific requirementsProvide country specific requirements to GSCM impacting site contracts’ processPrepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical studyNegotiate within client approved contract and budget templates and negotiation parametersCommunicate with sites and internal personnel regarding the status of contracts and contract related documentsArrange translation of the final country CTA template and/or final negotiated contracts, where applicableProvide the final/draft CTA and site budget for submission, where requiredObtain site signature as well as Sponsor/Allucent signature, as applicableKeep up to date with applicable local regulations impacting clinical trial contractsAssist in preparing the site-specific Essential Document Package and sending to sitesResponsible for collection and first review of Essential DocumentsProvide the Global Essential Document Reviewer with the collected documents for independent reviewFollow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolutionObtain authorization for the shipment of Investigational Product to the siteTrack relevant information and data in CTMS and/or other tracking toolsTo be successful you will possess:Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.Experience with contract negotiation.A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.A thorough understanding of the drug development processGood oral and written communications skills - fluent in Spanish and English.Attention to detail.Able to perform well as a team member.Disclaimers:*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. xqbhyrx Candidates should never be submitted directly to our hiring managers, employees, or human resources.”#LI-BL1#J-18808-Ljbffr
