[Alexion] Country Study Manager

Job Description

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 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...