Director, Study Start Up

Job Purpose/ Summary:
The Director, Study Start-Up & Process Improvement is responsible for leading and optimizing cross-functional processes that support site activation activities. This role serves as the central point of responsibility in driving clinical trial site activation cycle time, collaborating across Feasibility, Regulatory Operations, Contracting, Budgeting, Clinical Monitoring, and Project Management to ensure efficient and timely study start-up execution.
This position will be office based at our Covington, KY or Raleigh, NC location.
What You'll Do:

• Lead and coordinate study start-up activities across internal teams and external stakeholders
• Serve as the primary leadership contact for site selection and activation timelines for specified client programs
• Design and implement optimal processes to streamline site activation workflows
• Assess, enhance, and/or implement data collection mechanisms, and maintain metrics to assess performance and identify areas for improvement
• Collaborate with Feasibility, Regulatory Operations, Contracting, Budgeting, Clinical Monitoring, and Project Management to align goals, objectives, and deliverables with respect to start-up
• Monitor progress and resolve issues that may impact study start-up timelines
• Provide strategic input to improve operational efficiency and compliance

What You'll Bring:

• Bachelor's degree in life sciences, healthcare, or related field
• Minimum 5 years of experience in a role with significant process improvement expertise requirements (e.g., Six Sigma, Lean)
• Minimum 5 years of experience in clinical research in a CRO setting
• Deep knowledge of study start-up processes and site activation
• Minimum 2 years of experience in a managerial or leadership role
• Master's degree in life sciences, healthcare, or business administration preferred
• Experience with global clinical trials and regulatory environments

About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an

email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ) or from our verified LinkedIn page.

Please Note

• We will never communicate with you directly via Microsoft Teams Messaging or by text message
• We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Veterans/Disabled