Менеджер проекта

ICON plc is a world-leading healthcare intelligence and clinical research organization that shapes the future of clinical development through innovation and excellence.

• Shape and execute Study Start-Up strategies across global, multi-country studies;
• Lead the development and delivery of comprehensive Study Start-Up Plans, covering regulatory, ethics, and contract execution;
• Drive end-to-end start-up activities from site identification through to IP release;
• Provide strategic input at Bid Defence and Kick-Off meetings;
• Oversee regulatory and ethics submissions to ensure high-quality, compliant, and timely approvals;
• Manage site contract and budget negotiations in collaboration with legal, finance, and sponsors;
• Identify risks, dependencies, and bottlenecks, implementing mitigation and escalation strategies;
• Partner with Project Managers and cross-functional stakeholders to integrate start-up within overall study delivery;
• Ensure accuracy, quality, and inspection readiness of study documentation, including CTMS and eTMF oversight;
• Lead and coordinate Study Start-Up team members;
• Drive process consistency and continuous improvement across regions;
• Maintain oversight of study metrics, budgets, and scope of work;
• Provide clear, structured reporting to sponsors and internal leadership.

• Proven, recent experience with Study Start-Up as a primary responsibility, including end-to-end ownership of site activation;
• 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;
• Ability to collaborate effectively across cross-functional, global teams;
• Structured, proactive, and solution-oriented approach to delivery.

• Competitive salary;
• Various annual leave entitlements;
• Health insurance offerings;
• Retirement planning offerings;
• Global Employee Assistance Programme (LifeWorks);
• Life assurance;
• Flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments).