Site Manager

About the Role

The Site Manager reports directly to the assigned Regional Site Manager and is responsible for the deployment, oversight, and maintenance of Elite Clinical Network (ECN) processes in the conduct of clinical trials. This role includes full accountability for all site staff and operations. The Site Manager ensures clinical trials are conducted efficiently, in compliance with regulatory requirements, and in alignment with company objectives, fostering a high-performing, patient-centric research environment.

Responsibilities

• Manage all aspects of study execution from initiation through close-out, ensuring adherence to timelines, high-quality protocol execution, and compliance with ECN processes.
• Monitor and manage site-level revenue and expenses, collaborating with finance and leadership to track study billing, manage budgets, and control costs to maximize profitability.
• Create and implement detailed operational plans for each study, including staffing, equipment, resource allocation, and timelines.
• Ensure accurate and timely regulatory reporting in accordance with GCP, ICH guidelines, and applicable regulations. Maintain documentation and audit readiness.
• Oversee data integrity through routine documentation review, source verification, and efficiency checks, ensuring compliance with study protocols and regulatory expectations.
• Meet participant recruitment and enrollment goals by implementing proactive strategies and monitoring performance.
• Serve as the primary point of contact for Sponsors, CROs, and vendors, ensuring timely communication and resolution of operational issues.
• Provide training and onboarding for new site staff, ensuring understanding of protocol requirements, regulatory guidelines, and site procedures.
• Plan and lead regular site team meetings to foster communication, address challenges, and ensure consistency across functions.
• Collaborate with the Regional Site Manager and attend leadership meetings to align study progress with organizational priorities.
• Oversee staff evaluation, selection, and performance management to ensure team competency and support for study operations.
• Maintain and audit the site’s master training file, including staff certifications and licensure, to ensure compliance.
• Develop and maintain collaborative relationships with monitors, project managers, vendors, and sponsor representatives.
• Review monitoring visit follow-up letters, implement corrective actions, and maintain compliance and quality standards.
• Monitor site performance trends, identify areas for improvement, and implement strategies for operational efficiency.
• Cultivate professional relationships with affiliated physicians and engage additional physicians as needed to support study requirements.

Qualifications

• Bachelor’s degree in a scientific or healthcare field.
• Minimum of 5 years in clinical research management or applicable management experience.

Skills

• Excellent written and verbal communication skills.
• Advanced management skills with the ability to lead a team.
• Ability to organize and manage multiple projects and priorities.
• Commitment to the vision and mission of Elite Clinical Network.
• Experience working with IRBs, Sponsors/CROs, and vendors.
• Extensive knowledge of Microsoft Office, RealTime CTMS, GCP, and industry standards.
• Demonstrated ability to learn quickly and solve complex problems.
• Ability to work independently and within a multi-disciplinary team.

Site Operations Expectations

• On-Site Presence: Monday through Friday, standard operating hours, minimum 8 hours per day, 40 hours per week.
• Time Off Protocol: Prior notification and approval required from the Regional Site Manager.
• Coverage Responsibility: Ensure operational duties are covered during absences, coordinating with team members for seamless operations.

Pay

Annual Salary: $50,000 - $70,000 with site profit sharing.