ClinLab Solutions Group · 1 week ago
Director, Study Start Up & Process Improvement
Raleigh, NC
Full-time
Hybrid
Lead/Staff, Director/Executive
$140K/yr - $175K/yr
5+ years expClinLab Solutions Group is seeking a Director, Study Start-Up & Process Improvement to lead and optimize cross-functional processes that support site activation activities. This role involves driving clinical trial site activation cycle time by collaborating with various teams to ensure efficient study start-up execution.
BiotechnologyRecruitingStaffing Agency
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
Qualification
Required
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
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
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
Preferred
Master's degree in life sciences, healthcare, or business administration
Experience with global clinical trials and regulatory environment
Company
ClinLab Solutions Group
ClinLab Solutions Group is one of the only scientific resourcing firms that seamlessly supports the entire lifecycle — from early discovery through clinical development to commercialization.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Steve Naclerio
Executive Vice President, Operations
Adam Katz
EVP of People & Development
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