Director, Site Start Up
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Job Description
Director leading site start-up delivery for Precision for Medicine, a precision medicine clinical research services organization. Overseeing SSU teams, regulatory submissions, contracts, KPIs, risk management, and global clinical trial execution.
Responsibilities:
- Provides leadership, guidance, and overall support to the Site Start-up team across project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes
- Supports management of site start-up delivery across IRB/EC submissions, Competent Authorities submissions, governing organizations, site contracts, budget negotiations, and other start-up requirements
- Establishes the SSU framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluations, and mitigations
- Supports collaboration with Clinical Operations, project management, and other cross-functional departments in planning, execution, and governance of SSU activities
- Supports corporate and departmental business strategies and acts as an ambassador for change management
- Provides leadership and oversight for large or increasingly complex SSU programs
- Manages escalations and remediation of SSU concerns
- Optimizes processes and delivery to meet or exceed SSU budget targets
- Partners with Global Resourcing to assess and manage SSU leads, specialists, and Site Contract Management staff
- Supports team career development, growth, succession planning, and compliance activities
- Coordinates SSU Lead participation in client meetings and presentations
- Collaborates with Business Development on opportunities, proposals, budgeting, and bid defense preparation
- Supports SSU project strategy, delivery, evaluations, and required changes
- Develops, measures, and reports SSU KPIs and leads continuous improvement
- Reinforces company culture and values to motivate, engage, and retain the SSU team
Requirements:
- Bachelor's degree in life sciences or related field, or equivalent combination of education, training, and experience
- Minimum 12 years 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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