Director, Site Start Up
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Job Description
Director leading site start-up operations for Precision for Medicine, a global clinical research services organization. Overseeing SSU strategy, delivery, compliance, teams, and continuous improvement across European markets.
Responsibilities:
- Provide leadership, guidance, and overall support to the Site Start-up team across project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes
- Support management of site start-up delivery through direct management and cross-functional oversight of IRB/EC submissions, Competent Authority submissions, governing organizations, site contracts, budget negotiations, and other start-up requirements
- Establish the SSU framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluation, and mitigation
- Coordinate SSU activities with Clinical Operations, project management, and other cross-functional departments globally and regionally
- Support corporate and departmental business strategies and act as an ambassador for change management
- Provide leadership and oversight for large and increasingly complex SSU programs
- Manage escalations and remediate SSU concerns
- Optimize processes and delivery to support profitability and budget targets
- Partner with Global Resourcing teams to assess and manage SSU team members and meet cost, time, and quality goals
- Support career development, growth, succession planning, policy, and regulatory compliance
- Support SSU Lead participation in client meetings and presentations
- Collaborate with Business Development on opportunities, proposals, budgeting, and bid defense
- Support project strategy, delivery, evaluations, and required changes
- Develop, measure, and report SSU KPIs and lead continuous improvement
- Reinforce company culture and values, motivate the 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 orientation
- Proven experience in strategic planning, risk management, and change management
- Fluency in English
Benefits:
- Discretionary annual bonus
- Private medical insurance
- MultiSport Card
- Life insurance
- Pension
- Home working allowance
- Vacation
- Other benefits
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