What are the responsibilities and job description for the Director, Study Start Up & Process Improvement position at ClinLab Solutions Group?
About the Company
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/Cincinnati, OH or Raleigh, NC location. It is eligible for a hybrid schedule of 3 days in the office and 2 days remote work.
About the Role
Lead and coordinate study start-up activities across internal teams and external stakeholders.
Responsibilities
- 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
Qualifications
- 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 environment
Required Skills
- Must have strong study start up, experience working with clinical program management, clinical monitoring, site activations, feasibility team, experience with process improvement.
- Looking for a true driver, leader, someone who will take action.
- Minimum 5 years of experience in a role with significant process improvement expertise requirements (e.g., Six Sigma, Lean).
- Needs formal training like Six Sigma-black belt/yellow belt, Lean, Kaizen, Operational Excellence training. If they don’t have formal training but has implemented in career, that would work.
- Need CRO background as sponsor or site experience only won’t be a fit.
- Must have clinical study start up background.
- No direct reports to start, might be in future.
- Client focuses mostly on rare disease, oncology, organ transplant, but that experience isn’t required.
Salary : $140,000 - $175,000