Senior Study Start-Up Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Study Start-Up Manager based in the United States.

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. This opportunity is well suited to an organized, proactive clinical research professional who enjoys influencing teams and building scalable operational solutions.

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1