Project Manager, Feasibility Site Activation
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Job Description
Project Manager overseeing global clinical study start-up strategies at ICON. Leading cross-functional collaboration for effective regulatory and contract execution across participating countries.
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 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
Requirements:
- 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:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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