Director, Study Start Up & Process Improvement

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.

It is eligible for a hybrid schedule of 3 days in the office and 2 days remote work.

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 www.ctifacts.com

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 unparall...