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Allucent

Global drug development services for biotech

Start-Up Associate 2

Clinical Research Operations +1Confirmed live in the last 24 hours
Full-timeMilan, Metropolitan City of Milan, ItalyNo salary listed

About the Job

Requirements

  • A Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution is required.
  • More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry is required.
  • Thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines is required.
  • A thorough understanding of the drug development process is required.
  • Fluency in Italian and English, with good oral and written communication skills, is required.
  • Attention to detail is required.
  • The ability to perform well as a team member is required.

Responsibilities

  • Track relevant information, data, progress, and milestones for assigned start-up activities in CTMS or other tracking tools.
  • Ensure planned dates are reliable and up to date in CTMS departments and study teams.
  • File documents in the electronic Trial Master File for which the associate is the document owner.
  • Assist other Study Start-up team members with filing documents in the electronic Trial Master File for which they are document owners.
  • Assist in preparing, compiling, submitting, and maintaining local-level regulatory documentation required by regulatory agencies for clinical trials.
  • Provide relevant documents in compliance with local regulations.
  • Support review of technical, pre-clinical, and clinical reports for regulatory submissions.
  • Interact with regulatory authorities.
  • Prepare and compile responses to questions raised by regulatory agencies and submit the responses.
  • Regularly check for updates to regulations, guidelines, and procedures, and communicate and circulate updates as appropriate.
  • Support the Global Regulatory Manager and/or Global Submission Specialist as needed.
  • Prepare, compile, submit, and maintain local-level ethical requirements and documentation required by the Independent Ethics Committee or Institutional Review Board for clinical trials.
  • Assist in providing and reviewing relevant documents in compliance with ethical requirements and local legislation.
  • Interact with the Independent Ethics Committee or Institutional Review Board.
  • Prepare and compile responses to questions raised by the Independent Ethics Committee or Institutional Review Board and submit the responses.
  • Regularly check for updates to ethical regulations, guidelines, and procedures, and communicate and circulate changes and updates as appropriate.
  • Assist in adapting country Site Initiation Forms and Investigator Site Files to site-specific requirements.
  • Provide country-specific requirements to Global Site Contract Management that affect the site contracts process.
  • Prepare, review, negotiate, and finalize Clinical Trial Agreements, Letters of Indemnification, 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 about the status of contracts and contract-related documents.
  • Arrange translation of the final country Clinical Trial Agreement template and/or final negotiated contracts where applicable.
  • Provide the final or draft Clinical Trial Agreement and site budget for submission where required.
  • Obtain site signatures and Sponsor/Allucent signatures as applicable.
  • Keep up to date with applicable local regulations affecting clinical trial contracts.
  • Assist in preparing the site-specific Essential Document Package and sending it to sites.
  • Collect and perform the first review of Essential Documents.
  • Provide collected documents to the Global Essential Document Reviewer for independent review.
  • Follow up with sites regarding document discrepancies noted by the Global Essential Document Reviewer until they are resolved.
  • Obtain authorization for shipment of Investigational Product to the site.
  • Track relevant information and data in CTMS or other tracking tools.

About the Company

Allucent

Global drug development services for biotech

Allucent provides global drug development services aimed at small and mid-sized biotech firms. Its offerings include therapeutic strategies, clinical trial operations, biometrics, and clinical pharmacology to support regulatory planning and execution. The company works by partnering with biotech teams to design and run clinical studies, extend in-house capabilities, and ensure accurate data collection and analysis across more than 60 countries. It differentiates itself by focusing on smaller biotech clients with end-to-end, globally coordinated development programs, backed by deep regulatory and scientific expertise and long-term collaborations. The goal is to help clients bring new therapies to market safely and efficiently through practical, hands-on development support.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Cary, NC
Founded
2022

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