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Precision for Medicine is seeking a Director of Site Start-up to lead the Site Start-up (SSU) department across European operations. This role provides strategic leadership and operational oversight of the SSU function, which manages clinical trial site initiation activities including informed consent form review, regulatory document collection, IRB/EC/CA submissions, and site contract negotiations.
Key responsibilities include:
- Provide leadership, guidance, and support to the SSU team on project delivery, communication, HR, revenue enhancement, and process improvement
- Manage site start-up delivery through direct team management and cross-functional oversight of IRB/Ethics Committee submissions, Competent Authority submissions, and site contracts
- Collaborate with the Head of Site Start-up to establish the SSU framework, tools, methodology, and risk mitigation strategies
- Partner with Clinical Operations, project management, and other departments on global and regional SSU planning and execution
- Lead large and complex SSU programs, manage escalations, and ensure timely remediation of concerns
- Optimize processes to improve profitability and meet budget targets
- Assess and manage team members (SSU leads, specialists, site contract staff) to ensure cost, time, and quality goals are met
- Support team career development, growth, and succession planning
- Coordinate SSU participation in client meetings and business development activities
- Develop, measure, and report SSU KPIs and drive continuous improvement
- Ensure compliance with regulatory requirements, ICH Guidelines, Good Clinical Practices, and company SOPs
The role works closely with the Head of Site Start-up on departmental strategy, corporate business strategy, and organizational change management. Candidates can work remotely from the UK, Spain, Poland, Hungary, Serbia, Slovakia, or Romania.
