Clinical Trial Site Operations Manager

Hawthorne Health

Clinical Trial Site Operations Manager overseeing operational oversight and performance of multiple clinical research sites. Partnering with clinical teams to ensure high-quality execution and compliance.

Posted 5/28/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $85,000 - $120,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide operational oversight and support for multiple clinical research sites within the network.
Monitor site performance metrics including enrollment, retention, protocol compliance, data quality, query resolution, and study timelines.
Ensure consistent implementation of SOPs, operational workflows, and best practices across all assigned sites.
Identify operational gaps and implement process improvement initiatives to enhance efficiency and site performance.
Support study startup activities including feasibility, site activation, staffing readiness, staff training, and sponsor/CRO coordination.
Partner with site leadership to optimize resource allocation, staffing coverage, and workflow management.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Support audit readiness and assist with sponsor, CRO, and regulatory inspections/audits.
Monitor protocol deviations, CAPAs, and quality-related issues and collaborate with site teams on corrective actions.
Promote a culture of compliance, quality, and patient safety throughout the site network.
Serve as a primary operational partner to PIs, Sub-Is, CRCs, and site staff.
Provide mentorship, coaching, and operational guidance to clinical research personnel.
Assist with onboarding, training, and ongoing development of site staff.
Foster strong collaboration and communication across cross-functional teams and site locations.
Track and report on key operational and financial metrics across assigned sites.
Support achievement of enrollment targets, study milestones, and organizational growth initiatives.
Collaborate with leadership on strategic initiatives, expansion opportunities, and operational scaling efforts.

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Healthcare Administration, Business Administration or related field preferred.
5+ years of clinical research experience required.
2+ years of multi-site operational leadership or management experience preferred.
Strong knowledge of GCP, FDA regulations, ICH guidelines, and clinical trial operations.
Experience working with Sponsors, CROs, PIs, and site networks.
Demonstrated ability to manage multiple priorities across multiple locations.
Strong leadership, communication, organizational, and problem-solving skills.
Proficiency in CTMS, IRT, EDC systems, Microsoft Office, and clinical research technology platforms.
Highly preferred: Experience within a multi-site clinical research network or SMO environment.
Therapeutic area experience in areas such as CNS, cardiology, metabolic, oncology, or vaccine studies.
Experience supporting audit readiness and regulatory inspections.
Prior experience leading operational improvement initiatives and scaling research operations.

Benefits

Comp & perks

Remote role with regular travel to assigned research sites as needed.
Ability to travel up to 30%.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical researchoperational leadershipprocess improvementenrollment managementprotocol compliancedata qualityaudit readinessregulatory inspectionsCAPA managementmulti-site management

Soft Skills

leadershipcommunicationorganizational skillsproblem-solvingmentorshipcollaborationcoachingoperational guidanceresource allocationworkflow management

Certifications

Bachelor's degree in Life SciencesBachelor's degree in Healthcare AdministrationBachelor's degree in Business Administration