Collins McNicholas

It’s an amazing opportunity for being part of a successful team in one of the most important Biopharma Companies in Ireland.

 

As part of the Clinical Trial Capabilities Team you will:

 

  • Ensure that the Investigator sites meet the requirements to enrolling study participants into clinical trials.
    • Collecting and submitting regulatory documents
    • Being the point of contact for a site’s ERB and Competent Authority when applicable
    • Communicate and negotiate budgets with site personnel and internal teams.
    • Negotiate and obtain a fully-executed contract.
    • Ensure site compliance to required training.
    • Drive timelines aligned with Company priorities.

 

  • Support ongoing activities during site maintenance and closeout.
    • Communicate directly with sites to enable start-up and maintain an active collaboration with sites.
    • Identify, communicate and resolve issues
    • Ensure Country-specific regulatory and data privacy requirements are incorporated and all documents/systems.
    • Populate internal systems to ensure the accuracy of trial/site performance.

 

  • Obtain clinical trial authorizations and ethical approvals.
  • Ensure Inspection readiness through an accurate and available Trial Master File.
  • Provide feedback and shared learning for continuous improvement.
  • Understand and comply with procurements, legal and financial requirements and procedures.
  • Anticipate and monitoring dynamically changing priorities.

 

Requirements:

  • Bachelor’s degree
  • 2 year’s clinical research experience or relevant experience
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation.
  • Applied knowledge of project management processes and sills
  • Appreciation of / experience in compliance-driven environment
  • Ability to learn and comply with financial and legal guidelines and policies.
  • Fluent in English and
    • Italian or,
    • French or,
    • German, Spanish, Italian, Polish, Swedish, Danish, Finnish, Czech, Hungarian, Romanian, Dutch, Flemish, Swiss German, Austrian German, Slovakian, Arabic, Hebrew, Russian, Ukrainian, and Turkish

 

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@collinsmcnicholas.ie

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