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Project Manager, Feasibility & Site Activation (Home-Based)

icon · Warsaw

New Remote
Remote Mid 🇬🇧 English
CTMS eTMF CA/EC submissions ICH-GCP

Job description

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Project Manager, Feasibility & Site Activation, you will drive the successful start-up of global clinical studies, taking ownership of the Study Start-Up (SSU) strategy and execution so that sites are activated efficiently, regulatory pathways are navigated effectively and studies are ready for delivery from day one. The role is described as home-based.

Key responsibilities

  • Shape and execute Study Start-Up strategies across global, multi-country studies, aligned with timelines, scope and sponsor expectations.
  • Develop and deliver Study Start-Up Plans covering regulatory, ethics and contract execution across all participating countries.
  • Run end-to-end start-up activities from site identification through to IP release, keeping key milestones accountable.
  • Contribute to Bid Defence and Kick-Off meetings, influencing study design and start-up feasibility.
  • Oversee regulatory and ethics submissions for timely, compliant approvals.
  • Manage site contract and budget negotiations with legal, finance and sponsors.
  • Identify risks, dependencies and bottlenecks and implement mitigation and escalation strategies.
  • Ensure accuracy, quality and inspection readiness of study documentation, including oversight of CTMS and eTMF activities.
  • Lead and coordinate Study Start-Up team members and drive process consistency and continuous improvement.
  • Monitor study metrics, budgets and scope of work, and report clearly to sponsors and leadership.

Required profile

  • Bachelor's degree in Life Sciences or a related field.
  • Recent Study Start-Up experience with end-to-end site activation responsibility.
  • Experience supporting global and multi-country clinical trials.
  • Experience managing site contracts, budgets and start-up timelines.
  • Solid understanding of ICH-GCP and applicable regulations.

Required skills

  • Strong knowledge of CA/EC submissions, CTA processes and regulatory requirements.
  • Working knowledge of CTMS, eTMF and other clinical systems.
  • Strong stakeholder management, communication and collaboration skills.

What we offer

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
  • Retirement and pension plans, life assurance and disability coverage.
  • Employee assistance programmes and learning and development opportunities.

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Source : ats:workday

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Published 10 hours ago

Expires 1 month from now

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