Director, Site Start Up
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Job Description
Director leading site start-up for Precision for Medicine, a precision clinical research services organization. Overseeing SSU delivery, regulatory submissions, contracts, teams, risk management and continuous improvement.
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 globally and regionally
- Support corporate and departmental business strategies
- Act as an ambassador for change management during global structural evolution and PFM growth
- Provide leadership and oversight for SSU programs, including large and increasingly complex programs
- Manage escalations and remediation of SSU concerns
- Optimize processes and delivery to support SSU profitability and budget targets
- Partner with Global Resourcing to assess and manage SSU leads, specialists and site contract management staff
- Support team career development, growth and succession planning while ensuring policy and regulatory compliance
- Coordinate SSU Leads’ participation in client meetings and presentations
- Collaborate with Business Development on opportunity development, proposals, budgeting and bid defense
- 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 PFM values, culture, engagement and retention within the SSU team
Requirements:
- Bachelor’s degree in life sciences or 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, including CTMS, eTMF and EDC
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail and customer service demeanor
- Proven strategic planning, risk management and change management experience
- Fluency in English
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