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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 critical clinical trial initiation activities including informed consent form review, regulatory document collection, IRB/EC/CA submissions, and site contract negotiations.
Key responsibilities include:
- Providing leadership, guidance, and support to the SSU team on project delivery, communication, HR, revenue enhancement, and process improvement
- Managing site start-up delivery through direct team management and cross-functional oversight of regulatory submissions, competent authority interactions, and site contracting
- Collaborating with the Head of Site Start-up to establish SSU frameworks, tools, methodologies, and risk mitigation strategies
- Supporting cross-functional coordination with Clinical Operations, project management, and other departments on global and regional SSU activities
- Leading large and complex SSU programs, managing escalations, and ensuring timely remediation of concerns
- Optimizing processes to enhance profitability and meet budget targets
- Partnering with Global Resourcing teams to assess and manage SSU leads, specialists, and site contract management staff
- Supporting team career development, succession planning, and compliance with company policies and regulatory guidelines
- Coordinating SSU participation in client meetings and business development activities
- Developing, measuring, and reporting SSU KPIs to drive continuous improvement
- Ensuring conduct and delivery of clinical trials in compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices
The role reports to the Head of Site Start-up and requires expertise in clinical trial operations, regulatory compliance, and team leadership. Candidates must be comfortable working remotely across UK, Spain, Poland, Hungary, Serbia, Slovakia, and Romania.
