Director, Clinical Trial Site Operations

Hawthorne Health

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

Posted 5/9/2026full-timeRemote • 🇺🇸 United StatesLead💰 $145,000 - $165,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
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.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Remote work options
Up to 30% travel
Tools and resources for team collaboration

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchsite operations managementoperational strategiesperformance metricsregulatory submissionsauditsCAPAsdata-driven decision makingSOP developmenttrial start-up

Soft Skills

leadershipcommunicationorganizational skillsmentoringcollaborationaccountabilitycontinuous improvementproblem-solvingteam managementtraining development