Senior Study Start-Up Manager

About the role

This is a senior clinical operations role responsible for driving study start-up activities from site identification through activation and ongoing submissions. You will help ensure clinical trials launch efficiently, on schedule, and in compliance with ICH/GCP, applicable regulations, and internal procedures. The role spans the Americas, providing opportunities to influence processes across the U.S., Canada, and Latin America. You will serve as a key subject-matter resource for study teams while improving workflows, metrics, tools, and operational practices. The position combines hands-on study start-up expertise with leadership, mentoring, resource planning, and cross-functional collaboration. You will work closely with clinical and external partners to resolve issues, reduce cycle times, and improve trial execution.

Accountabilities

• Own study start-up, initial and ongoing submission activities, ensuring delivery within established timelines, quality standards, ICH/GCP requirements, internal procedures, and local regulations.
• Lead and coordinate start-up activities from site identification and feasibility through site activation, proactively managing timelines, risks, dependencies, and issues.
• Provide country-specific study start-up expertise to project teams across the Americas, including the United States, Canada, and Latin America.
• Engage sites during feasibility, execute confidentiality agreements, collect relevant information, and collaborate with internal stakeholders to support strategic site selection.
• Use knowledge of therapeutic areas and site capabilities to recommend potential first sites and activation strategies that support first-patient-in objectives.
• Lead kick-off activities and drive completion of start-up tasks while leveraging existing site relationships and partnership data to reduce cycle times.
• Manage document preparation, negotiation, collection, and submission activities, including informed consent documentation and central IRB submissions.
• Act as the lead contact for central IRB set-up through close-out and facilitate relevant start-up forums and discussions.
• Track start-up metrics and KPIs, identify trends and risks, and implement process improvements that increase efficiency and quality.
• Maintain and enhance study start-up resources and tools, including regional toolboxes, workflows, and supporting infrastructure.
• Support resource allocation, forecasting, onboarding, training, and functional planning across the start-up organization.
• Provide back-up study start-up leadership when needed and contribute to broader departmental and project objectives.
• Directly manage team members through onboarding, regular one-to-ones, performance discussions, goal setting, workload assessment, coaching, and development.
• Provide functional oversight and mentoring for external service-provider resources, partnering with their leadership to maintain performance, training, and communication standards.

Requirements

• Bachelor's degree or higher in a scientific or healthcare discipline preferred.
• 7+ years of progressive experience in clinical research and clinical operations, preferably within biotechnology, pharmaceutical, or CRO environments.
• Strong expertise in clinical trial study start-up activities, including site feasibility, selection, documentation, submissions, IRB processes, and activation.
• Thorough understanding of ICH/GCP, relevant country-specific regulations and guidelines, and clinical trial operating procedures.
• Experience working within a Functional Service Provider (FSP) model and managing or collaborating with external service-provider teams.
• Previous line management experience, including interviewing, onboarding, training, performance management, mentoring, and team development.
• Strong ability to prioritize multiple activities, manage timelines, mitigate risks, and consistently follow through on commitments.
• Excellent written and verbal communication skills, with the ability to influence stakeholders and drive timely issue resolution.
• Highly organized, analytical, detail-oriented, and comfortable working in a complex, fast-paced clinical research environment.
• Demonstrated ability to identify process improvements and develop practical solutions that improve study start-up efficiency.
• Proficiency with Microsoft Office, including Outlook, Word, Excel, PowerPoint, and Teams.
• Willingness to travel up to 10%.
• Strong collaboration, initiative, adaptability, continuous-learning mindset, and results orientation.

Benefits

• Base salary of $136,400–$181,400 annually, with actual compensation determined by experience, skills, education, certifications, and work location.
• Eligibility for an annual bonus plan for non-commercial roles.
• Eligibility for discretionary equity awards and participation in an Employee Stock Purchase Plan.
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
• Life insurance.
• Paid time off.
• Wellness benefits and programs.
• Remote work opportunity within the United States.
• Opportunity to contribute to clinical development programs with an international scope and meaningful patient impact.
• Collaborative environment focused on professional development, operational excellence, and continuous improvement.