Director, Site Start Up
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Job Description
Director leading site start-up operations for Precision for Medicine, a clinical research organization. Guiding global trial start-up delivery, regulatory submissions, contracts, risk management, and team development.
Responsibilities:
- Provide leadership 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, including IRB/Ethics Committee submissions, Competent Authority submissions, site contracts, budget negotiations, and other start-up requirements
- Establish the Precision for Medicine Site Start-up framework, including intelligence, tools, methodology, risk evaluations, and mitigations
- Collaborate with Clinical Operations, project management, and other cross-functional departments on global and regional Site Start-up planning, execution, and governance
- Support corporate and departmental business strategies and change management for organizational growth and expansion
- Provide leadership and oversight on complex Site Start-up programs
- Manage escalations and remediation of Site Start-up concerns
- Optimize processes and delivery to support profitability and budget targets
- Partner with Global Resourcing to assess and manage Site Start-up leads, specialists, and site contract management staff
- Support team career development, growth, succession planning, and compliance with company policies and regulatory guidelines
- Coordinate Site Start-up Lead participation in client meetings and presentations
- Collaborate with Business Development on opportunity development, proposals, budgeting, bid defense preparation, and attendance
- Support Site Start-up project strategy and delivery with global and regional functional leaders
- Evaluate Site Start-up activities and implement required project changes
- Develop, measure, and report Site Start-up 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 of 12 years in clinical research, including extensive Site Start-up experience
- Extensive leadership experience or proven competencies for the position
- 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 to interface effectively in a team setting
- 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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