Director, Clinical Trial Site Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the daily operations of all Hawthorne Health trial sites, including both decentralized and hybrid models.

• Convert study scopes into operational strategies, which encompass Manuals of Operations and project governance documentation.

• Ensure effective trial start-up, participant recruitment, execution, monitoring, and completion activities.

• Create and standardize operational policies, standard operating procedures (SOPs), and performance metrics to enhance quality and consistency across sites.

• Guarantee compliance with ICH/GCP guidelines, FDA regulations, company SOPs, and specific requirements set by sponsors.

• Manage regulatory submissions, obtain IRB/IEC approvals, and oversee site compliance documentation.

• Track site performance metrics, conduct audits, and implement corrective and preventive actions (CAPAs) to maintain quality standards.

• Protect patient confidentiality and ensure adherence to HIPAA/PHI regulations.

• Guide, mentor, and develop site managers, coordinators, HEROs, and cross-functional operational personnel.

• Establish training frameworks for project-level and site-level execution to guarantee consistency and preparedness.

• Cultivate a culture of teamwork, accountability, and continuous improvement.

⛳️ Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree is preferred).

• 8–10+ years of progressive experience in clinical research, with a robust background in site operations and management.

• A proven history of leading high-performing teams and achieving operational success within clinical trial settings.

• Comprehensive knowledge of GCP, ICH, FDA regulations, and decentralized/hybrid trial methodologies.

• Exceptional leadership, communication, and organizational capabilities, with the ability to manage intricate, cross-functional initiatives.

• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC), and other related technologies.

• Strong analytical and problem-solving abilities, with a knack for making data-driven decisions.

🏝️ Benefits

• Options for remote work.

• Up to 30% travel.

• Access to tools and resources for team collaboration.