Associate Director, Clinical Trial Start-Up

• Lead or provide oversight of development and execution of study-level start-up strategies, country/site activation plans, and risk mitigation approaches through SSU roles and/or CRO
• Develop site activation projections and provide input into study timeline development through data-driven assessment of country requirements, historical timelines, predictive data, and emerging technologies
• Serve as a Subject Matter Expert in global study, country, and site start-up pathways
• Partner cross-functionally to deliver start-up insights and strategies informing country and site selection, timelines, and activation strategies
• Track and analyze SSU performance metrics, identify trends and issues, and address and communicate risks
• Leverage historical and predictive data, real-world evidence, and emerging technologies to optimize start-up strategies and activation processes
• Oversee SSU team members, providing guidance, training, and performance feedback
• Oversee CROs/vendors executing start-up activities, including performance tracking against KPIs and timelines
• Lead or contribute to initiatives improving start-up methodology, quality, tools, and process efficiency
• Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions
• Participate in development and refinement of global SSU policies, SOPs, and training curricula
• Represent SSU in industry discussions, cross-industry collaboration efforts, and internal governance meetings

Requirements

• Recognized as a subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways
• Proven ability to drive cross-functional decision-making through data-driven insights
• Demonstrated success supporting or leading global clinical start-up strategy in both in-house and outsourced models, specifically oversight of CROs or vendors
• Experience leveraging digital technologies to inform study planning and start-up optimization
• Ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings
• Strong leadership, collaboration, and communication skills, with the ability to influence cross-functional teams and external partners
• Proficiency with CTMS, document management systems, and SSU technology platforms (e.g., Veeva Vault)
• Experience in assessment or utilization of AI in this SSU space preferred
• Experience contributing to inspection readiness and continuous process improvement initiatives
• 10% to 20% travel, US and International
• Bachelor’s degree in life sciences or related field required
• 8-10 years of experience in clinical research, with at least 5 years focused on clinical trial start up or site activation

Core Competencies

Demonstrates expertise in clinical site start-up strategies, regulatory requirements, and cross-functional collaboration to optimize study timelines and activation processes. Proven ability to lead teams, analyze performance metrics, and implement continuous improvement initiatives in clinical research.

Highest-signal resume keywords

• Clinical Site Start-Up Expertise
• Cross-Functional Decision-Making
• CTMS Proficiency
• Leadership in Clinical Research
• Data-Driven Insights

ATS Optimization Keywords

Hard Skills

• Clinical Trial Start-Up
• Site Activation Pathways
• Risk Mitigation Strategies
• Data Analysis
• Predictive Data Utilization
• Regulatory Compliance
• Performance Metrics Tracking
• Continuous Process Improvement
• Operational Strategy Development
• AI Utilization in SSU

Soft Skills

• Leadership
• Collaboration
• Communication
• Influencing Skills
• Strategic Thinking

Industry Keywords

• Global Regulatory Requirements
• IRB/EC Processes
• CRO Oversight
• Study Planning
• Inspection Readiness

Tools & Technologies

• CTMS
• Document Management Systems
• SSU Technology Platforms
• Veeva Vault