Director, Site Start-up
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Job Description
Director leading site start-up for Precision for Medicine, a precision medicine clinical research services organization. Overseeing global SSU delivery, regulatory submissions, contracts, budgets and team development.
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 oversight of site start-up delivery, including IRB/EC submissions, Competent Authority submissions, governing organizations, site contracts and budget negotiations
- Establish the PFM Site Start-up framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluations and mitigations
- 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 or complex SSU programs
- Manage escalations and remediation of SSU concerns
- Optimize processes and delivery to meet or exceed budget targets
- Partner with Global Resourcing on assessment and management of SSU team members
- Support career development, growth and succession planning while ensuring compliance with company policies and regulatory guidelines
- Coordinate SSU Lead participation in client meetings and presentations
- Collaborate with Business Development on opportunity development, proposals, budgeting and bid defenses
- Support SSU project strategy, delivery, evaluations and required changes
- Develop, measure and report SSU KPIs and lead continuous improvement
- Reinforce PFM 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 demeanor
- Proven experience in strategic planning, risk management and change management
- Fluency in English
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