Start-Up Associate II

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