Project Manager FSA

• Driving site activation: Leading and managing the successful activation of sites from identification to IP release across multiple countries and projects.
• Study start-up planning: Developing, implementing, and overseeing Study Start-Up Plans, including integration into the Project Management Plan and alignment with sponsor expectations.
• Stakeholder collaboration: Acting as the primary point of contact for sponsors and internal teams including Regulatory, Contracts, CTMs, and Site ID, ensuring transparency and alignment across functions.
• Regulatory ethics submissions: Overseeing submissions to Regulatory Authorities, Ethics Committees (ECs), and other relevant bodies, ensuring timely and high-quality execution.
• ICF and document review: Managing the development, finalization, and review of Master and Country-Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs), as we'll as EU Clinical Trial Application forms (where applicable).
• Contract budget management: Coordinating site contract and budget negotiations, tracking site activation costs, identifying out-of-scope activities, and supporting change order processes.
• Timeline management: Forecasting and tracking study timelines and deliverables, identifying potential roadblocks, and implementing proactive mitigation strategies.
• Team leadership: Leading cross-functional SSU teams across regions, mentoring junior staff, and contributing to team development and training initiatives.
• Reporting communication: Preparing and delivering study metrics and regular updates to internal and external stakeholders, supporting client meetings and bid defenses.
• Quality compliance: Ensuring compliance with ICON SOPs, ICH-GCP, and local regulatory requirements, with responsibility for documentation accuracy and audit readiness.

• Minimum 8 years of experience in Study Start-Up activities, including global project oversight.
• Strong knowledge of EUCTR, ICH/GCP, and global regulatory requirements for site activation.
• Experience managing budgets, contracts, and timelines across multiple global studies.
• Excellent leadership, communication, and organizational skills with a proven ability to work cross-functionally.
• Hands-on experience coordinating with global and regional teams to ensure on-time site initiation.
• Previous client-facing experience including Bid Defense and Kick-Off Meetings is preferred.
• Ability to manage competing priorities and maintain attention to detail in a fast-paced environment.

What ICON can offer you: