Director, Site Start Up
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Job Description
Director leading Site Start-up for Precision for Medicine, a global precision clinical research services organization. Managing SSU delivery, regulatory submissions, contracts, teams, risks, KPIs, and continuous improvement.
Responsibilities:
- Provide leadership, guidance, and support to the Site Start-up team across project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes
- Support management and cross-functional oversight of site start-up delivery, including IRB/EC and Competent Authority submissions, 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 collaboration with Clinical Operations, project management, and other functions in planning, execution, and governance of global and regional activities
- 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 meet or exceed budget targets
- Partner with Global Resourcing to assess and manage SSU leads, specialists, and site contract management staff
- Support career development, growth, and succession planning for the SSU team
- Coordinate SSU Lead participation in client meetings and presentations
- Collaborate with Business Development on opportunities, proposals, budgeting, and bid defenses
- 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
- Reinforce Precision for Medicine’s culture and values to motivate, engage, and retain the SSU team
Requirements:
- Bachelor’s degree in life sciences or a related field, or equivalent combination of education, training, and experience
- Minimum 12 years of clinical research experience, 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, such as 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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