Site Manager – Clinical Trial Operations

This is a fully remote position, open to applicants in Alabama, +3 more states.

📋 Description

• Provide operational leadership and on-site assistance for multiple clinical research sites within the designated region.

• Act as the main operational resource for assigned sites, proactively identifying and eliminating obstacles to successful study implementation.

• Coordinate and execute vendor agreements and partnerships that facilitate efficient site operations.

• Assist with study startup activities, including feasibility assessments, site activation, staffing readiness, staff training, and coordination with sponsors/CROs.

• Track study performance metrics such as enrollment, retention, protocol adherence, data quality, query resolution, and study timelines.

• Recognize operational challenges and implement scalable process improvements to boost efficiency and site performance.

• Collaborate with leadership to develop and standardize operational processes, workflows, and best practices throughout the expanding site network.

• Ensure compliance with GCP, FDA regulations, ICH guidelines, HIPAA, sponsor protocols, and internal quality standards.

• Assist in audit readiness and support sponsor, CRO, and regulatory inspections.

• Monitor protocol deviations, CAPAs, and quality-related issues while collaborating with site teams on corrective measures.

• Foster a culture of compliance, quality, and patient safety across all assigned sites.

• Establish trusted relationships with Principal Investigators, Sub-Investigators, Clinical Research Coordinators, pharmacists, and site personnel.

• Act as a hands-on operational partner, offering guidance, troubleshooting, and daily support to assigned sites.

• Aid in the onboarding, training, and continual development of site staff while encouraging consistency across the network.

• Navigate complex site and investigator relationships with professionalism, collaboration, and a solutions-oriented mindset.

• Cultivate strong communication and collaboration among cross-functional teams and site locations.

• Build and sustain robust working relationships with Sponsors, CROs, vendors, and external partners.

• Represent Hawthorne Health professionally during sponsor meetings, operational reviews, and issue escalations as necessary.

• Ensure prompt communication and resolution of operational issues that may affect study execution or sponsor satisfaction.

• Track operational KPIs and convey site performance trends and opportunities to leadership.

• Support the achievement of enrollment targets, study milestones, and operational performance goals.

• Collaborate with leadership on new site launches, network expansion, and strategic operational initiatives.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or a related field is preferred.

• A minimum of 5 years of clinical research experience is required, with recent hands-on site experience (CRC, Lead CRC, Site Manager, or similar) strongly preferred.

• Strong understanding of GCP, FDA regulations, ICH guidelines, and clinical trial operations.

• Experience collaborating with Sponsors, CROs, Principal Investigators, and clinical research sites.

• Proven ability to manage multiple priorities across various locations while maintaining a keen attention to detail.

• Excellent communication, organizational, relationship-building, and problem-solving abilities.

• Proficiency in CTMS, EDC systems, Microsoft Office, and other clinical research technology platforms.

• Willingness and ability to travel regularly throughout Tennessee, Alabama, North Carolina, and South Carolina.

🏝️ Benefits

• Remote position with occasional travel to assigned research sites as needed.

• Ideal candidates should be located in EST or CST time zones.

• Ability to travel up to 30%.