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Head Of Monitoring |

hace 3 meses


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..We are a private, recently created, and non-profit Foundation, linked to the Hospital Clinic Barcelona, whose mission is to strengthen people's health and improve the quality of life of citizens. To respond to our founding goals, we have a CRO (Barcelona Coordinating Center, BCCC) for conducting clinical studies, initiated by the pharmaceutical and medical device industry or by researchers, offering a comprehensive portfolio of services to meet the needs of our customers.What We Are Looking for:We are seeking a Head of Monitoring.The main functions will be the organization,coordination and supervision of monitoring activities to ensure the effective and efficient delivery of the Monitoring Department in accordance with applicable regulations, requirements, and procedures.He/she will lead the team of Clinical Research Associates (CRAs) and will ensure appropriate coordination with the other departments, will participate in managerial activities, as appropriate, and will report to senior management.Responsibilities:Coordinate site and monitoring activities across clinical studies to maintain quality standards.Ensure adequate training for all monitoring staff including external freelancers.Ensure compliance is maintained.Review percentage of trip reports, metrics, protocol deviations and follow-up items, to evaluate compliance and ensure corrective and preventative actions are implemented.Identify monitoring trends across clinical studies and communicate them within trial team and Clinical Operations Team.Perform co-monitoring visits when needed.Maintain oversight of the CRAs and CTAs workload and perform forecast of activities to allocate resources in an effective way.Keep track of the in and out of scope monthly hours of the monitoring department staff versus the agreed budgeted hours.Interact with Trial Team members and CRO/vendor personnel, as needed.Oversee site inspection readiness, including appropriateness of Trial Master File (TMF).Support site and Sponsor audits and inspections.Participate in investigator meetings and trainings to ensure quality.Conduct additional checks as outcome of internal medical monitoring/clinical checks, as needed.Participate in KPI determination for CROs and vendors.Attend governance meetings with vendors, when applicable.Ensure quality of vendor ´s monitoring systems, tools and templates including vendor selection processes.Oversee monitoring visit scheduling and monitoring performance metrics via spot checks.Liaise with CPMs to ensure that vendor proposals for monitoring tasks are adequate.Develop and maintain monitoring SOPs, templates, and tools, including risk-based and centralized monitoring.Regular reporting to senior management.Contribute as appropriate to the relevant Monitoring Plans.Requirements:Bachelor's Degree, preferably in life science