Senior Study Start-Up Manager

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.