• 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.
  • Ability to perform the duties of a Clinical Research Coordinator and actively perform CRC responsibilities at sites as needed

• Exceptional leadership and team-building capabilities
• Excellent verbal and written communication skills
• Highly organized with strong attention to detail and compliance
• Proficient in Clinical Trial Management Systems (CTMS) and Microsoft Office Suite
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment
• Ability to adapt to frequent changes in responsibilities and workloads.
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• Proven ability to maintain site profitability

Certifications/Licenses, Education, and Experience

• Minimum 5 years of clinical research experience, with 1+ years in a leadership role required
• Multi-site management experience preferred
• 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.