[Hiring] Senior Project Manager, Feasibility Site Activation @ICON plc

Role Description

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.

• 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 Defense 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.

Qualifications

• 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

• 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.

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.