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...