Central Monitoring Manager

Central Monitoring Manager #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Performs the Central monitoring activities for multiple studies and ensure accurate tracking and status reporting of studies in his/her remit. Manage portfolio of studies for a Customer and act as a customer point of contact Collaborates in the development Central Monitoring proposal text and review of costing, contributes to proposal strategy and development. Collaborates in the development of sponsor presentations/bid defense support. Oversees at a study/customer level the appropriate tracking, interpretation and application of data to proactively manage risk Ensures that tracking and status reporting are performed in a timely and accurate manner. Applies data to recommend any required changes Leads, plans, prepares, conducts and follows up the central monitoring (Site, subject & study level review as applicable) activities and supports less experienced team members Supports PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting. Ensures Critical Data & Process Definition are implemented in EDC design by Data Expert Conducts Site Risk Assessment across multiple studies, works with study start up team members, reviews site outreach, Pre-Study Visit reports and Site Risk Assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels