Site Manager

Job Description

Job Description

Position Summary

The Site Manager 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 is responsible for the daily operational oversight and overall performance of a clinical research site. This role ensures that clinical trials are conducted efficiently, in compliance with regulatory requirements, and in alignment with company objectives. The Site Manager oversees site staff, coordinates resources, monitors key performance indicators, and fosters a high-performing, patient-centric research environment.

Roles and Responsibilities :

• Manage all aspects of study execution from initiation through close-out to ensure adherence to projected timelines, high-quality protocol execution, and full compliance with internal ECN processes.
• Monitor and manage site-level revenue and expenses, ensuring financial targets are achieved. Collaborate with finance and leadership to track study billing, manage budgets, review payment schedules, and control costs to maximize site profitability and financial health.
• Create and implement detailed operational plans tailored to each study, including staffing, equipment, resource needs, and timelines, ensuring effective resource allocation and protocol compliance.
• Ensure accurate and timely completion of all regulatory reporting in accordance with GCP, ICH guidelines, and applicable local, national, and international regulations. Maintain documentation and audit readiness at all times.
• Oversee data integrity through routine documentation review, source verification, and efficiency checks. Ensure accuracy, completeness, and compliance of all collected data with study protocols and regulatory expectations.
• Maintain accountability for timely and accurate data entry and reporting. Monitor submission timelines to ensure sponsor and regulatory deadlines are met without exception.
• Meet or exceed all participant recruitment and enrollment goals by implementing proactive recruitment strategies and monitoring enrollment performance.
• Serve as the primary point of contact for Sponsors, CROs, and vendors, ensuring timely communication, resolution of operational issues, and alignment on study deliverables.
• Provide comprehensive training and onboarding for new site staff, ensuring protocol requirements, regulatory guidelines, and site-specific procedures.
• Plan and lead regular site team meetings to foster communication, address operational challenges, share study updates, and ensure consistency across clinical and administrative functions.
• Collaborate closely with the Regional Site Manager and attend required leadership meetings to ensure alignment of study progress with organizational priorities and performance targets.
• Oversee the evaluation, selection, and performance management of research staff to ensure staffing adequacy, team competency, and support for study operations.
• Maintain and routinely audit the site’s master training file, including staff certifications, licensure, and training records, to ensure compliance and readiness for inspections.
• Develop and maintain collaborative relationships with monitors, project managers, vendors, and sponsor representatives, facilitating streamlined operations and issue resolution.
• Develop and maintain assigned source documentation in accordance with protocol specifications, ensuring data quality, consistency, and real-time updates throughout the study lifecycle.
• Review monitoring visit follow-up letters promptly, identify findings or recommendations, and implement / document corrective and preventive actions to maintain compliance and quality standards.
• Monitor site and clinic performance trends regularly, proactively identifying areas for improvement and implementing corrective strategies to drive operational efficiency and excellence.
• Cultivate and maintain a professional, respectful working relationship with all affiliated physicians, ensuring alignment of clinical responsibilities and fostering site-level collaboration.
• Identify and engage additional physicians when needed to support protocol-specific assessments or examinations, ensuring study timelines and requirements are consistently met.

Education and Experience

Knowledge and Skills Required

Site Operations Expectations

Email Communication Protocol

Sponsor and CRA Communication