Description
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 Project Manager – Feasibility & Site Activation, you will play a critical role in driving the successful start-up of global clinical studies.
Responsibilities
- 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
Your Profile
- 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
Rewards & 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