Project Manager, Feasibility & Site Activation (Home-Based)
icon · Warsaw
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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Published 9 godzin temu
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