Site Manager, Clinical Trial Operations

About the Role

Hawthorne Health is seeking a Clinical Trial Operations Site Manager to support and grow multiple research sites across Tennessee, Alabama, North Carolina, and South Carolina. This role is ideal for someone who enjoys being in the field, building strong site relationships, and helping establish operational excellence in a fast-growing organization. Regular travel throughout the assigned territory is required.

As one of our early Site Managers, you’ll have a unique opportunity to help shape the future of our site operations. You’ll be joining a team that is actively building and standardizing processes, workflows, and best practices across our growing network. If you’re energized by creating structure, solving problems, and driving continuous improvement, this role offers the chance to make a meaningful impact.

This is a highly hands-on position. We’re looking for someone with recent clinical research site experience who enjoys rolling up their sleeves and supporting day-to-day operations. Success in this position requires a collaborative mindset, strong organizational skills, and the ability to build trusted relationships with Principal Investigators, site staff, and external vendors.

This role is ideal for someone who enjoys building from the ground up and wants the opportunity to influence how site operations evolve as Hawthorne Health continues to expand its site network.

Key Responsibilities

Site Operations & Oversight
• Provide operational leadership and on-site support for multiple clinical research sites across the assigned region.
• Serve as the primary operational resource for assigned sites, proactively identifying and removing barriers to successful study execution.
• Coordinate and execute vendor agreements and partnerships that support efficient site operations.
• Support study startup activities including feasibility, site activation, staffing readiness, staff training, and sponsor/CRO coordination.
• Monitor study performance metrics including enrollment, retention, protocol compliance, data quality, query resolution, and study timelines.
• Identify operational challenges and implement scalable process improvements to enhance efficiency and site performance.
• Partner with leadership to build and standardize operational processes, workflows, and best practices across the growing site network.
Clinical & Regulatory Compliance
• Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, sponsor protocols, and internal quality standards.
• Support audit readiness and assist with sponsor, CRO, and regulatory inspections.
• Monitor protocol deviations, CAPAs, and quality-related issues while partnering with site teams on corrective actions.
• Promote a culture of compliance, quality, and patient safety across all assigned sites.
Site Leadership & Relationship Management
• Build trusted relationships with Principal Investigators, Sub-Investigators, Clinical Research Coordinators, pharmacists, and site staff.
• Serve as a hands-on operational partner by providing guidance, troubleshooting, and day-to-day support to assigned sites.
• Support onboarding, training, and ongoing development of site personnel while promoting consistency across the network.
• Navigate complex site and investigator relationships with professionalism, collaboration, and a solutions-oriented approach.
• Foster strong communication and collaboration across cross-functional teams and site locations.
Sponsor, CRO & Vendor Partnerships
• Build and maintain strong working relationships with Sponsors, CROs, vendors, and external partners.
• Represent Hawthorne Health professionally during sponsor meetings, operational reviews, and issue escalation as needed.
• Ensure timely communication and resolution of operational issues that may impact study execution or sponsor satisfaction.
Business & Performance
• Monitor operational KPIs and communicate site performance trends and opportunities to leadership.
• Support achievement of enrollment goals, study milestones, and operational performance objectives.
• Collaborate with leadership on new site launches, network expansion, and strategic operational initiatives.

Qualifications

Required
• Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or a related field preferred.
• 5+ years of clinical research experience required with recent hands-on site experience (CRC, Lead CRC, Site Manager, or similar) strongly preferred.
• Strong knowledge of GCP, FDA regulations, ICH guidelines, and clinical trial operations.
• Experience working with Sponsors, CROs, Principal Investigators, and clinical research sites.
• Demonstrated ability to manage multiple priorities across multiple locations while maintaining strong attention to detail.
• Excellent communication, organizational, relationship-building, and problem-solving skills.
• Proficiency with CTMS, EDC systems, Microsoft Office, and other clinical research technology platforms.
• Ability and willingness to travel regularly throughout Tennessee, Alabama, North Carolina, and South Carolina.
Highly Preferred
• Experience supporting operations across a multi-site clinical research network or SMO.
• Experience building or improving operational processes within a growing organization.
• Demonstrated success developing strong working relationships with Principal Investigators and navigating complex site environments.
• Experience supporting audit readiness and regulatory inspections.
• Therapeutic area experience across multiple indications such as cardiology, CNS, metabolic, vaccines, dermatology, or respiratory studies.

Additional Information

• Remote role with regular travel to assigned research sites as needed.
• Ideal candidates will be located in EST or CST timezones.
• Ability to travel up to 30%.