Region Manager

About the role

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.

Responsibilities

• 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 internal leadership.
• Advocate for site needs and promote transparency in communication across all stakeholders.
• Risk Mitigation & Problem Solving
• Identify and proactively address potential risks or operational issues.
• Work collaboratively with internal teams to implement effective solutions and improve site efficiency.

Qualifications

• Minimum 5 years of clinical research experience, with 1+ years in a leadership role required.
• Demonstrated expertise in overseeing multiple clinical research trials across varying therapeutic areas required.
• Strong understanding of GCP, FDA regulations, ICH guidelines, and industry best practices required.
• Bachelor’s Degree preferred, or equivalent combination of education, training and experience.

Benefits & Perks

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match

Location & Travel

This is a remote position with up to 50% travel requirements. Required to be on site monthly at minimum.