Medix
Clinical Research Site Operations Manager - 245348
Medix, West Palm Beach, Florida, United States, 33412
Clinical Research Site Operations Manager (Outpatient)
Location:
West Palm Beach, FL (On-site only) Schedule:
Full-time, 40 hours/week (primarily during normal business hours, 9 AM - 5 PM) Direct Reports:
6–7 staff members, including Sub-Investigators
Position Summary: We are urgently seeking an experienced
Clinical Research Quality & Operations Manager
to oversee the daily operations and quality compliance of our outpatient clinical research site in West Palm Beach. This is a
fully management-focused role
— ideal for someone with strong leadership skills and a deep understanding of clinical trial operations. The successful candidate will be responsible for leading a multi-disciplinary team, ensuring GCP compliance, managing site performance, and maintaining sponsor relationships. While the manager may be listed on delegation logs as a contingency, the expectation is that they focus on
oversight , not hands-on coordination.
Key Responsibilities: Operational Oversight: Direct and oversee day-to-day research site activities including patient scheduling, visit flow, and protocol compliance. Manage site-level timelines to ensure data entry, query resolution, and monitoring visits are conducted within sponsor expectations. Coordinate cross-functional teams (CRCs, raters, regulatory, recruitment) to ensure operational efficiency. Forecast staffing needs and allocate resources based on study pipeline and patient volume.
Quality Management & Compliance: Develop, implement, and maintain the site's Quality Management System (QMS). Conduct internal audits and lead resolution of deviations through Corrective and Preventive Action (CAPA) plans. Ensure inspection readiness and GCP compliance across all ongoing studies. Maintain SOPs, oversee staff training, and ensure all training is documented and up to date. Oversee regulatory processes including IRB submissions, safety reporting, and protocol amendments.
Performance Metrics & Reporting: Track and report key site performance indicators (KPIs), such as: Enrollment targets and screen-fail rates Retention and visit completion rates Query resolution timelines Monitoring/audit outcomes and CAPAs Present performance dashboards to senior leadership and sponsors. Identify and address operational gaps through continuous improvement initiatives.
Sponsor & CRO Relations: Serve as the primary point of contact for sponsors, CROs, and monitors on site operations. Host site selection, initiation, monitoring, and closeout visits. Ensure timely responses to sponsor queries, data clarifications, and audit findings.
Team Leadership & Development: Lead, coach, and develop a team of 6–7 direct reports. Conduct regular staff meetings, performance evaluations, and training sessions. Foster a culture of accountability, quality, and continuous learning.
Requirements: Must have prior experience managing clinical research operations
(formal management title not required, but experience leading teams is essential). Strong understanding of the end-to-end clinical trial process, including regulatory, operational, and quality aspects. Experience managing timelines, resources, and multi-disciplinary teams in a research setting. Familiarity with GCP, FDA regulations, and sponsor/CRO communications. Excellent organizational, leadership, and communication skills. Ability to work occasional evenings or weekends, as needed (remote work acceptable for these hours).
Work Environment: This is an
on-site role
based at our
West Palm Beach outpatient location . Standard schedule is Monday through Friday during regular business hours. Intermittent work outside normal hours (evenings/weekends) may be required, generally remote-capable.
West Palm Beach, FL (On-site only) Schedule:
Full-time, 40 hours/week (primarily during normal business hours, 9 AM - 5 PM) Direct Reports:
6–7 staff members, including Sub-Investigators
Position Summary: We are urgently seeking an experienced
Clinical Research Quality & Operations Manager
to oversee the daily operations and quality compliance of our outpatient clinical research site in West Palm Beach. This is a
fully management-focused role
— ideal for someone with strong leadership skills and a deep understanding of clinical trial operations. The successful candidate will be responsible for leading a multi-disciplinary team, ensuring GCP compliance, managing site performance, and maintaining sponsor relationships. While the manager may be listed on delegation logs as a contingency, the expectation is that they focus on
oversight , not hands-on coordination.
Key Responsibilities: Operational Oversight: Direct and oversee day-to-day research site activities including patient scheduling, visit flow, and protocol compliance. Manage site-level timelines to ensure data entry, query resolution, and monitoring visits are conducted within sponsor expectations. Coordinate cross-functional teams (CRCs, raters, regulatory, recruitment) to ensure operational efficiency. Forecast staffing needs and allocate resources based on study pipeline and patient volume.
Quality Management & Compliance: Develop, implement, and maintain the site's Quality Management System (QMS). Conduct internal audits and lead resolution of deviations through Corrective and Preventive Action (CAPA) plans. Ensure inspection readiness and GCP compliance across all ongoing studies. Maintain SOPs, oversee staff training, and ensure all training is documented and up to date. Oversee regulatory processes including IRB submissions, safety reporting, and protocol amendments.
Performance Metrics & Reporting: Track and report key site performance indicators (KPIs), such as: Enrollment targets and screen-fail rates Retention and visit completion rates Query resolution timelines Monitoring/audit outcomes and CAPAs Present performance dashboards to senior leadership and sponsors. Identify and address operational gaps through continuous improvement initiatives.
Sponsor & CRO Relations: Serve as the primary point of contact for sponsors, CROs, and monitors on site operations. Host site selection, initiation, monitoring, and closeout visits. Ensure timely responses to sponsor queries, data clarifications, and audit findings.
Team Leadership & Development: Lead, coach, and develop a team of 6–7 direct reports. Conduct regular staff meetings, performance evaluations, and training sessions. Foster a culture of accountability, quality, and continuous learning.
Requirements: Must have prior experience managing clinical research operations
(formal management title not required, but experience leading teams is essential). Strong understanding of the end-to-end clinical trial process, including regulatory, operational, and quality aspects. Experience managing timelines, resources, and multi-disciplinary teams in a research setting. Familiarity with GCP, FDA regulations, and sponsor/CRO communications. Excellent organizational, leadership, and communication skills. Ability to work occasional evenings or weekends, as needed (remote work acceptable for these hours).
Work Environment: This is an
on-site role
based at our
West Palm Beach outpatient location . Standard schedule is Monday through Friday during regular business hours. Intermittent work outside normal hours (evenings/weekends) may be required, generally remote-capable.