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.

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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 roleyour key tasks will include:

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- 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’ 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

- Communicate with sites and internal personnel regarding the status of contracts and contract related documents

- Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

- Provide the final/draft CTA and site budget for submission, where required

- Obtain site signature as well as Sponsor/Allucent signature, as applicable

- Keep up to date with applicable local regulations impacting clinical trial contracts

- Assist in preparing the site-specific Essential Document Package and sending to sites

- Responsible for collection and first review of Essential Documents

- Provide the Global Essential Document Reviewer with the collected documents for independent review

- Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

- Obtain authorization for the shipment of Investigational Product to the site

- Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

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- Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.

- More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.

- A thorough knowledge of the country or re

📌 Start-Up Associate II (Romano di Lombardia)
🏢 Allucent
📍 Romano di Lombardia