Country Study Manager

About this role

This is what you will do: 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 Country 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 r

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