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Clinical Project Manager - Post Trial Access

Poland, Gdansk · Job Posted May 28, 2026
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Job Description

As a Project Manager - Post Trial Access at ICON, you will be responsible for leading and coordinate project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards.

Job Responsibility

  • Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
  • Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
  • Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
  • Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
  • Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders
  • with support as needed
  • Ensure alignment across PTA program decisions, documentation, plans, and implementation
  • Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
  • Manage vendor contracting and deliverables in support of PTA/continued access program execution

Requirements

  • Experience in clinical research or biopharmaceutical operations
  • including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval
  • comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
  • General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
  • Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
  • Proven experience collaborating effectively
  • influencing stakeholders across functions and levels
  • Evidence of strong project management skills
  • including managing competing priorities and solving operational challenges in clinical or investigational program environments
  • Successful history of working independently in a global environment
  • Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement

Nice to have

Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage

What we offer

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

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