ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Project Manager, Feasibility Site Activation
Location
Poland
Posted
54 days ago
Salary
0
Seniority
Senior
Job Description
Project Manager, Feasibility Site Activation
ICON plc
• Shape and execute Study Start-Up strategies across global, multi-country studies, ensuring alignment with timelines, scope, and sponsor expectations • Lead the development and delivery of comprehensive Study Start-Up Plans, covering regulatory, ethics, and contract execution across all participating countries • Drive end-to-end start-up activities from site identification through to IP release, maintaining momentum and accountability for key milestones • Provide strategic input at Bid Defence and Kick-Off meetings, influencing study design and start-up feasibility from the outset • Oversee regulatory and ethics submissions, ensuring high-quality, compliant, and timely approvals across regions • Manage site contract and budget negotiations in collaboration with legal, finance, and sponsors, supporting timely site activation • Proactively identify risks, dependencies, and bottlenecks, implementing mitigation and escalation strategies to protect study timelines • Partner closely with Project Managers and cross-functional stakeholders, ensuring seamless integration of start-up within overall study delivery • Ensure accuracy, quality, and inspection readiness of all study documentation, including oversight of CTMS and eTMF activities • Lead and coordinate Study Start-Up team members, providing direction, support, and oversight to ensure consistent delivery • Drive process consistency and continuous improvement across regions, contributing to operational excellence initiatives • Maintain oversight of study metrics, budgets, and scope of work (SOW), ensuring delivery within agreed parameters • Provide clear, structured reporting and updates to sponsors and internal leadership, enabling informed decision-making
Job Requirements
- Proven, recent experience with Study Start‑Up (SSU) as a primary responsibility, including end‑to‑end ownership of site activation activities
- Experience delivering SSU across global or multi‑country clinical studies
- Strong knowledge of regulatory and ethics submission processes, including CA/EC and CTA strategy
- Experience coordinating site contracts and budgets within start‑up timelines
- Demonstrated ability to manage SSU timelines, risks, and competing priorities
- Hands‑on familiarity with CTMS, eTMF, and clinical trial systems
- Solid understanding of ICH‑GCP and applicable regulatory frameworks
- Strong stakeholder management and communication skills across sponsors, sites, and internal teams
- Ability to collaborate effectively across cross‑functional, global teams
- Structured, proactive, and solution‑oriented approach to delivery
Benefits
- 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
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