Director, Site Start-up
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Job Description
Director leading site start-up delivery for Precision for Medicine, a global precision medicine clinical research services organization. Overseeing SSU teams, regulatory submissions, contracts, budgets, compliance, and continuous improvement across European markets.
Responsibilities:
- Provide SSU team guidance, leadership, and overall support for project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes
- Support overall management of site start-up delivery through direct management and/or cross-functional oversight of IRB/EC submissions, Competent Authorities submissions, governing organizations, site contracts, budget negotiations, and other start-up requirements
- Establish the PFM SSU framework with the Head of Site Start Up, including SSU intelligence, tools, methodology, risk evaluations, and mitigations
- Support collaboration with Clinical Operations, project management, and other cross-functional departments in planning, execution, and governance of SSU activities
- Support corporate and departmental business strategies
- Act as an ambassador for change management as PFM’s global structure evolves
- Provide leadership and oversight on SSU programs, including large and increasingly complex programs
- Manage escalations and remediation of SSU concerns
- Optimize processes and delivery to meet or exceed budget targets
- Partner with Global Resourcing to assess and manage SSU team members and ensure cost, time, and quality goals
- Support SSU team career development, growth, and succession planning
- Coordinate SSU Lead participation in client meetings and presentations
- Collaborate with Business Development on opportunity development, proposals, budgeting, bid defense preparation, and attendance
- Work with global and regional functional leaders to support SSU project strategy and delivery
- Support SSU evaluations and implement required project changes
- Develop, measure, and report SSU KPIs and lead continuous improvement
- Uphold PFM values, quality commitments, policies, procedures, regulatory guidelines, and customer service standards
- Use communication skills and experience to reinforce culture, motivate the SSU team, maintain engagement, and drive retention
Requirements:
- Bachelor’s degree in life sciences or related field, or equivalent combination of education, training, and experience
- Minimum 12 years of experience in clinical research, including extensive Site Start-up experience
- Experience working for a Clinical Research Organisation (CRO)
- Experience in people management
- Expert knowledge of GCP/ICH guidelines and the clinical development process
- Demonstrated leadership track record
- Experience working in a team environment with resource management experience
- Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint
- Clinical software experience, including CTMS, eTMF, and EDC
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail, and customer service demeanor
- Proven experience in strategic planning, risk management, and change management
- Fluency in English
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