Clinical Research

• Operationally manage and oversee clinical investigative sites and clinical operations deliverables for clinical trials
• Train and oversee CRA activities, including CRA transitions
• Identify quality issues and trends in site performance and establish corrective action plans
• Ensure adherence to study plans, SOPs, ICH/GCP guidelines, regulations, laws, timelines, and budgets
• Serve as primary sponsor contact for site-specific operational issues and clinical deliverables
• Contribute to internal, sponsor, and investigator meetings
• Manage risk assessments and mitigation execution
• Manage site contacts, site training, monitoring performance, screening, and enrollment oversight
• Track site visit report metrics and assess protocol deviations and action items
• Develop the Monitoring Plan and contribute to study plans, manuals, reference materials, logs, and site instructions
• Prepare and conduct CRA training, coordinate and lead CRA meetings, and conduct quality assessment and co-monitoring visits
• Oversee SQV, SIV, SMV, and COV development, performance, quality, and completion
• Participate in business development activities, including client meetings, bid defenses, RFPs, and RFIs
• Contribute to departmental tools and process improvements
• Track, forecast, and reconcile project budgets and support change orders and financial planning
• Proactively identify issues, present solutions, and support delivery of clinical trials within agreed timelines and budgets
• Apply prior experience to solve complex issues, identify solutions, and analyze outcomes

Clinical Research jobs in Europe

Clinical Trial Manager