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Careaccess
Region Manager
operationsfull-timeUSA Remote
SALARY
Not listed
WORK TYPE
remote
JOB TYPE
full-time
INDUSTRY
healthcare
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About the role
How This Role Makes a Difference
We are seeking an experienced and dynamic Region Manager to lead the operations and performance of multiple clinical research sites. This role is critical in ensuring the successful execution of clinical trials in accordance with regulatory guidelines, timelines, and quality standards.
The ideal candidate is a results-driven leader with deep clinical research experience, strong regulatory knowledge, and a passion for team development, patient care, and operational excellence.
How You'll Make An Impact
- Site Operations & Oversight
- Oversee day-to-day operations at multiple clinical research sites within the region.
- Ensure trials are conducted in full compliance with Good Clinical Practice (GCP), FDA, ICH, and protocol requirements.
- Lead all phases of clinical trial execution including site initiation, monitoring, subject recruitment, and study close-out.
- Ensure consistent, high-quality data collection and timely patient enrollment across all sites.
- Leadership & Staff Development
- Lead, mentor, and support site-level teams, including Principal Investigators, Clinical Research Coordinators, and other staff.
- Promote a collaborative and high-performance work culture through coaching, development, and team-building.
- Proactively resolve site-level challenges and performance issues.
- Regulatory Compliance & Quality Assurance
- Ensure strict adherence to study protocols, IRB/ethics board guidelines, and applicable federal regulations.
- Conduct internal site audits and oversee corrective actions when necessary.
- Maintain accurate and timely documentation, including ICFs, AEs, SAEs, and source documents.
- Financial Oversight
- Manage site budgets and ensure adherence to financial agreements.
- Support contract negotiations and oversee invoicing and payment processes.
- Monitor and optimize financial performance at each site.
- Operational Strategy & Reporting
- Collaborate with sponsors, CROs, and internal departments to ensure seamless clinical trial execution.
- Monitor site performance metrics (e.g., enrollment, retention, data quality) and provide regular reports to leadership.
- Oversee proper management of site resources, investigational product inventory, and study supplies.
- Stakeholder & Relationship Management
- Build and maintain strong relationships with Principal Investigators and key site personnel.
- Serve as the main liaison between clinical research sites, sponsors, and CROs.
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