Project Manager, Feasibility Site Activation
ICON plc · Warsaw
Project Manager FSA - EUROPE - HomebasedICON 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.
About the role
At ICON plc, we are committed to improving and saving lives through clinical research. As a Project Manager – Feasibility & Site Activation, you will play a critical role in driving the successful start-up of global clinical studies.
This is a highly visible position where you will take ownership of the Study Start-Up (SSU) strategy and execution—ensuring that sites are activated efficiently, regulatory pathways are navigated effectively, and studies are positioned for successful delivery from day one.
You will work at the center of cross-functional collaboration, partnering with sponsors, internal teams, and sites worldwide to deliver start-up excellence at scale.
What You Will Be Doing
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
Your Profile
Bachelor's degree in Life Sciences or a related field.
Recent Study Start-Up (SSU) experience with end-to-end site activation responsibility.
Experience supporting global and multi-country clinical trials.
Strong knowledge of CA/EC submissions, CTA processes, and regulatory requirements.
Experience managing site contracts, budgets, and start-up timelines.
Working knowledge of CTMS, eTMF, and other clinical systems.
Solid understanding of ICH-GCP and applicable regulations.
Strong stakeholder management, communication, and collaboration skills.
Organized, proactive, and solution-oriented approach.
#LI-MK1 #LI-Remote
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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 wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply