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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/Ethics Committee submissions, and site contract negotiations.
The Director will work closely with the Head of Site Start-up to develop and implement SSU strategy, frameworks, and methodologies across the organization. Key responsibilities include:
• Leading and managing the SSU team, providing guidance on project delivery, communication, HR, and process optimization
• Overseeing site start-up delivery through direct management and cross-functional coordination with Clinical Operations, project management, and regulatory teams
• Establishing SSU intelligence tools, risk evaluation frameworks, and best-practice methodologies
• Managing complex, high-revenue programs and escalations with timely remediation
• Partnering with Global Resourcing to assess and manage team members (SSU Leads, Specialists, Site Contract Management staff)
• Supporting team career development, succession planning, and compliance with regulatory guidelines
• Collaborating with Business Development on proposals, budgeting, and bid defense
• Developing and reporting SSU KPIs, driving continuous improvement and profitability
• Ensuring clinical trial conduct complies with ICH Guidelines, Good Clinical Practices, and SOPs
• Acting as a change management ambassador for organizational growth and expansion
The ideal candidate will have extensive experience in clinical trial operations, regulatory compliance, and team leadership within the CRO or biotech sector.
