Clinical Trial Site Operations Manager
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AI Summary
About Us
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. Hawthorne leverages convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients. Our community-based model shortens timelines and helps bring better treatments to market, faster.
\nThe Clinical Trial Site Operations Manager is responsible for the operational oversight, performance, and day-to-day management of multiple clinical research sites within the organization's site network. This role partners closely with Principal Investigators (PIs), Sub-Investigators (Sub-Is), Clinical Research Coordinators (CRCs), pharmacy staff, and site leadership to ensure high-quality study execution, regulatory compliance, operational efficiency, and achievement of enrollment and business objectives.
The Clinical Trial Site Operations Manager serves as a key operational leader focused on optimizing site performance, supporting staff development, ensuring sponsor satisfaction, and maintaining audit-ready research operations across assigned locations.
Site Operations & Oversight
- 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.
Clinical & Regulatory Compliance
- 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.
Leadership & Staff Support
- 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.
- Support performance management initiatives in partnership with site leadership and Human Resources.
Sponsor & CRO Relationship Management
- Build and maintain strong working relationships with Sponsors, CROs, and external partners.
- Participate in sponsor meetings, operational reviews, and escalation management as needed.
- Ensure timely communication and resolution of operational issues impacting study execution or sponsor satisfaction.
Business & Performance Management
- 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.
- 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.
- 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.
- Remote role with regular travel to assigned research sites as needed.
- Ability to travel up to 30%.
Hawthorne Health is transforming the clinical trial landscape through an innovative site model that integrates research into community-based settings like local pharmacies. By meeting patients where they already receive care, we are improving access, strengthening trust, and driving more inclusive and efficient trials.
We welcome the opportunity to connect with individuals interested in being part of this evolving model.
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