Clinical Site Manager

The Clinical Research Site Manager oversees the daily operations of a clinical research site and ensures the successful execution of multiple clinical trials. This role provides strong operational leadership, drives regulatory compliance, supports patient recruitment and retention, and manages key relationships with sponsors, CROs, and vendors. The position is ideal for an experienced clinical research professional who is ready to step into full site management after serving in a lead role at a research site or similar environment, and who is passionate about high-quality research and patient safety.

• Provide leadership and oversight of day-to-day clinical trial operations across multiple concurrent studies.
• Ensure all studies are conducted in accordance with study protocols, sponsor requirements, Good Clinical Practice (ICH-GCP) guidelines, FDA regulations, and applicable federal and institutional requirements.
• Design, implement, and refine operational processes to improve site efficiency, patient enrollment, retention, and overall study execution.
• Collaborate closely with investigators, clinical research coordinators, regulatory personnel, and sponsors to achieve study milestones on time and within quality standards.
• Oversee patient recruitment and retention strategies to meet or exceed enrollment targets.
• Analyze recruitment metrics and trends, and implement process improvements to maximize patient participation.
• Work with study teams to identify barriers to enrollment and develop effective mitigation strategies.
• Serve as the primary operational liaison with sponsors, CROs, monitors, and external vendors, ensuring clear and proactive communication.
• Foster strong sponsor and vendor relationships through responsiveness, transparency, and consistently high-quality study execution.
• Coordinate and support sponsor and CRO activities, including site qualification visits, site initiation visits, monitoring visits, audits, and other on-site or remote assessments.
• Ensure ongoing compliance with Good Clinical Practice (ICH-GCP), FDA regulations and guidance, 21 CFR Parts 11, 50, 54, 56, and 312 as applicable, Institutional Review Board (IRB) requirements, and sponsor protocols and standard operating procedures.
• Oversee regulatory documentation and essential study files to maintain continuous audit readiness.
• Support internal quality assurance initiatives, including corrective and preventive action (CAPA) activities when issues are identified.
• Maintain accurate, complete, and contemporaneous source documentation for all study participants and procedures.
• Ensure data integrity and timely data entry within Electronic Data Capture (EDC) systems.
• Review study documentation and data for quality, consistency, and adherence to protocol and regulatory requirements.
• Supervise and mentor clinical research coordinators and other site staff, providing regular guidance and feedback.
• Support training and professional development initiatives for site personnel to enhance skills and maintain regulatory and procedural competence.
• Promote a culture of accountability, collaboration, continuous improvement, and research excellence across the site.
• Manage multiple studies simultaneously while maintaining high standards of quality, compliance, and patient safety.
• Contribute to process improvement initiatives that optimize clinical operations, documentation practices, and site performance metrics.

• Minimum of 5+ years of clinical research experience, including site-level operations and study management responsibilities.
• Demonstrated expertise in Good Clinical Practice (GCP) and ICH-GCP guidelines.
• Strong knowledge of FDA regulations and 21 CFR requirements, including Parts 11, 50, 54, 56, and 312 as applicable.
• Proven experience with regulatory compliance, audit preparedness, and maintaining essential study documentation.
• Hands-on experience with source documentation practices and Electronic Data Capture (EDC) systems.
• Demonstrated success in patient recruitment and enrollment strategies for clinical trials.
• Experience managing sponsor and vendor relationships, including sponsors, CROs, monitors, and external vendors.
• Proven ability to manage multiple clinical studies simultaneously while maintaining quality and compliance standards.
• Strong leadership skills with experience supervising or leading clinical research staff.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with internal teams and…