Director, Study Start Up & Process Improvement jobs in United States
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CTI Clinical Trial and Consulting Services · 4 days ago

Director, Study Start Up & Process Improvement

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization focused on the advancement of treatments for chronically and critically ill patient populations. The Director, Study Start-Up & Process Improvement is responsible for leading and optimizing cross-functional processes that support site activation activities, ensuring efficient and timely study start-up execution.

BiotechnologyConsultingPharmaceutical
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Growth Opportunities

Responsibilities

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

Qualification

Process ImprovementClinical ResearchStudy Start-Up ProcessesGlobal Clinical TrialsLeadership ExperienceBachelor’s DegreeMaster’s DegreeStrategic InputCollaboration Skills

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

Preferred

Master's degree in life sciences, healthcare, or business administration
Experience with global clinical trials and regulatory environments

Benefits

Career progression through a structured mentoring program
Leadership courses
Tuition reimbursement
Dedicated training department
Generous health benefits
Vacation packages
Hybrid work from home opportunities
Paid parental leave
CTI Cares program

Company

CTI Clinical Trial and Consulting Services

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CTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services.