Sr. Clinical Site Manager

hace 1 semana


Madrid, España Engineeringuk A tiempo completo

.As a Senior Clinical Site Manager, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities, as well as supervision of all site-related activities to ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory requirements. Engage with clinical sites to develop, build, and maintain strong relationships with investigators/staff to ensure high-quality investigative sites to support UCB's clinical development programs. Collaborate with internal and external stakeholders as well as third-party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen, and develop high-quality investigative sites to support clinical development programs.What you will be doing:The Clinical Site Manager is a hybrid position: 30% Monitoring, 70% Site Engagement.Site Engagement Deliverables:Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stakeholders throughout the life cycle of client clinical trials.Support the clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles, and using motivational tactics to ensure timely delivery of trials.Engage, evaluate, and develop a global network of high-performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of the client and its activities, thereby increasing their desire to partner with the client.Develop and maintain relationships with site engagement organizations; assist in the identification of high-performing sites and key opinion leaders that can contribute to client forums, boards, and/or discussions.Interact/train new investigators to work on client clinical trials.Monitoring Deliverables:Responsible for all kinds of site visits (e.G., Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites' performance regarding set-up, conduct, and data collection.Primary contact for sites regarding study-related issues.Responsible for the early engagement with Key Opinion Leaders (KOLs)/sites/patient organizations and key contact point for these throughout the study.Attend key therapeutic trainings/meetings and/or industry trainings.Support CPM in management of the study, including but not limited to:Vendor managementLogisticsSelections of SitesMaintenance of study trackingOversight of the eTMFClose cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at the site



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