Allucent is hiring a
Local Start-Up Specialist in Spain

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Local Start-Up Specialist
🏢 Allucent
💵 ~$61k-$76k
📍Spain
📅 Posted on Jun 11, 2024

Summary

The job is for a Local Start Up Specialist I/II (LSUS) at Allucent™. The role involves coordinating local site start-up activities, including document collection, Regulatory Authority submission/approval, and acting as a main line of communication to RA/IEC/IRB. The position is hybrid/remote and requires a Life Science degree or equivalent qualification, 2+ years of experience in regulatory affairs, good communications skills in English and Spanish, and knowledge of country competent authority requirements.

Requirements

  • Life Science degree or equivalent qualification from an appropriate accredited institution
  • More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
  • Thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines
  • Thorough understanding of the drug development process
  • Good oral and written communications skills - fluent in English and Spanish
  • Attention to detail
  • Able to perform well as a team member

Responsibilities

  • 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
  • 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

Benefits

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
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