Director, Clinical Trial Site Operations

Operational Leadership: 

• Oversee day-to-day operations of all Hawthorne Health trial sites, including decentralized and hybrid models. 

• Translate study scopes into operational strategies, including Manuals of Operations and project governance documents. 

• Ensure efficient trial start-up, recruitment, conduct, monitoring, and close-out activities. 

• Develop and standardize operational policies, SOPs, and performance metrics to optimize quality and consistency across sites. 

Compliance & Quality Oversight 

• Ensure adherence to ICH/GCP guidelines, FDA regulations, company SOPs, and sponsor-specific requirements. 

• Oversee regulatory submissions, IRB/IEC approvals, and site compliance documentation. 

• Monitor site performance metrics, conduct audits, and implement CAPAs to uphold quality standards. 

• Safeguard patient confidentiality and maintain compliance with HIPAA/PHI regulations. 

Team Leadership & Development 

• Lead, mentor, and develop site managers, coordinators, HEROs, and cross-functional operational staff. 

• Build training frameworks for project-level and site-level execution to ensure consistency and readiness. 

• Foster a culture of collaboration, accountability, and continuous improvement. 

• Provide coaching and career development to build a strong pipeline of operational leaders. 

Performance Management 

• Define, track, and report KPIs related to site operations (enrollment, data quality, protocol adherence, and timelines). 

• Identify operational risks and develop proactive solutions to mitigate delays or quality concerns. 

• Report operational performance to executive leadership, providing data-driven insights and recommendations. 

Stakeholder Collaboration 

• Act as the escalation point for site-level operational challenges. 

• Partner with sponsors, CROs, investigators, vendors, and internal functions to ensure trial success. 

• Represent site operations in leadership forums and cross-functional initiatives. 

• Strengthen relationships with HEROs, cultivating engagement and alignment with study requirements.