Country Study Manager (Alexion)

Country Study Manager Location: Warsaw Hybrid Model: 3 days per week from office The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM may have responsibility for actively interacting with Regulatory Authorities / Ethics Committees in the Counrty and may support the submission and approval processes for assigned projects. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs.    The CSM will work closely with Head of Country Operations (HCO), and/or Associate Director Country Operations Manager (AD COM), to ensure adequate study resourcing. The CSM acts as local study manager and/or monitor of the study in compliance with SOPs and with protocol requirements. The CSM may also be required to perform site monitoring activities and/or oversight depending on the study requirements.    You will be responsible for:   • Quality and timeliness of  study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies). • Proactive reporting of study-specific issues (including monitoring metrics) to the global study team and country leadership team • Quality of monitoring oversight in the assigned study(ies) • Meeting recruitment targets for assigned study(ies). • CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party). • ICF customization at country/site level for the assigned studies. • Negotiation of site study contracts and budgets for the assigned studies at country level. • Review of local regulatory documentation and oversight of local regulatory activities. • Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities. • Leading recruitment discussions at local level for the assigned trials. • Timely and accurate responses to queries from the study team. • Conduct of site feasibility for allocated studies • Conduct and/or oversight of EC/CA submissions and facilitate resolution of queries. • Coordination of study specific training of CRAs for assigned trials. • Oversight of dedicated or FSP CRAs on assigned studies, when applicable. • Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. • Inspection readiness activities coordination at local level for assigned studies. • Driving quality efforts to proactively identify and manage risks to study quality. • Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP). • Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate. • Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles. • Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans. • Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV m