Providing Healthcare Employment Solutions
Clinical Trial Site Operations Manager
Location
United States
Posted
22 days ago
Salary
$85K - $120K / year
Seniority
Senior
Job Description
Clinical Trial Site Operations Manager
Hawthorne Health
• 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.
Job Requirements
- 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
- Remote role with regular travel to assigned research sites as needed.
- Ability to travel up to 30%.
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