hawthorne-health - Hawthorne Health - Director, Clinical Trial Site Operations

Hybrid - USA *1mo ago

Remote Director NA Life Sciences Clinical Research Clinical Director Reporting KPI Tracking GCP Documentation Team Leadership

Requirements

• Bachelor’s degree in life sciences, healthcare, or related field (advanced degree preferred). • 8–10+ years of progressive clinical research experience, with a strong background in site operations and management. • Proven track record of leading high-performing teams and driving operational success in clinical trial environments. • In-depth knowledge of GCP, ICH, FDA regulations, and decentralized/hybrid trial models. • Excellent leadership, communication, and organizational skills with ability to manage complex, cross-functional initiatives. • Proficiency in CTMS, EDC, and other clinical trial management technologies. • Strong analytical and problem-solving skills, with the ability to make data-driven decisions.

Responsibilities

• 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.