Regional Director of Clinical Operations
About The Position
Tekton Research is seeking an experienced Regional Director of Clinical Operations to oversee operational performance, revenue growth, and quality execution across clinical research sites. This strategic leadership role is responsible for ensuring sites achieve key performance indicators (KPIs), meet revenue objectives, maintain compliance with study requirements, and successfully execute clinical trials. The Regional Director of Clinical Operations serves as a key partner to site leadership, managers, and Principal Investigators (PIs), providing guidance, identifying business risks, implementing solutions, and reporting performance updates to executive leadership.
Requirements
- Clinical research operations and study management
- Regulatory requirements and compliance
- Clinical procedures and trial execution
- Sponsor communication and relationship management
- Project management principles
- Human resources and team leadership practices
- Operational performance management and KPI oversight
- Bachelor’s degree, specialized degree, or equivalent relevant education and experience preferred.
- 7–10 years of experience in the clinical research industry.
- 5+ years of experience in a supervisory or management leadership role.
- Proven experience managing clinical research operations, site performance, and cross-functional teams.
Responsibilities
- Monitor and evaluate study startup performance to support successful trial activation, revenue generation, and future business growth.
- Assess site revenue performance and provide strategic recommendations to achieve financial goals.
- Hold sites accountable for appropriate scheduling, recruitment strategies, and operational execution to meet or exceed recruitment and revenue targets.
- Provide oversight to ensure sites are appropriately staffed, trained, and prepared to meet study conduct requirements.
- Ensure sites maintain appropriate resources, equipment, and operational readiness for successful study execution.
- Monitor site compliance with contractual requirements, including completion of study visits, EDC entry, query resolution, and required documentation.
- Serve as a clinical research resource to support sites with operational and study-related questions.
- Ensure sites are conducting quality control activities and partner with Quality Assurance (QA) as needed for audits, inspections, and quality initiatives.
- Collaborate with site managers and Principal Investigators to ensure appropriate investigator coverage and study support.
- Communicate site goals, expectations, and performance metrics with managers and investigators.
- Track and report site performance, progress, challenges, and business risks to the Executive Director and/or COO.
- Develop and implement solutions to mitigate operational and business risks.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
