Senior Manager, Global Site Start Up Lead

Job Description:

• Develop and execute global site and country start-up strategies for complex clinical trials
• Identify risks, dependencies, and mitigation plans
• Lead site activation planning and forecasting activities to achieve study milestones and timelines
• Partner with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to drive study start-up execution
• Monitor and evaluate start-up metrics and use data and trends to improve performance and inform strategic decisions
• Oversee regulatory document collection, submissions, site initiation readiness, and milestone tracking
• Provide leadership and direction to CRO partners and internal teams for high-quality, compliant start-up delivery
• Serve as the primary escalation point for site start-up challenges
• Resolve issues proactively and drive cross-functional alignment
• Manage and develop a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives

Requirements:

• Bachelor's degree and 8+ years of pharmaceutical, biotechnology, or clinical research industry experience
• Extensive experience leading global clinical trial start-up activities, including country and site activation strategies
• Strong knowledge of ICH-GCP guidelines, clinical trial regulations, and global study start-up processes
• Demonstrated ability to lead cross-functional teams and influence stakeholders across a global organization
• Proven experience managing vendors and CROs, including performance oversight and issue resolution
• Excellent project management, communication, negotiation, and risk management skills
• Previous direct line management experience with responsibility for staff development and performance management preferred
• Experience supporting complex, high-profile, and global clinical development programs preferred
• Strong analytical mindset with a data-driven approach to forecasting, metrics review, and operational decision-making preferred
• Experience driving process improvements and operational excellence initiatives within Clinical Development preferred
• Advanced understanding of country-specific regulatory and site activation requirements across multiple regions preferred
• Ability to work primarily in a computer-based environment
• Ability to travel domestically and internationally up to 25% as required
• Ability to participate in meetings across multiple global time zones

Benefits:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Medical, dental, vision, life, and disability insurance benefits
• Paid time off
• Family support benefits
• Reasonable accommodation for applicants with known disabilities or chronic illnesses
• Remote work model
• Travel up to 25%