Senior Specialist, Country Study Start Up

Primary responsibilities include but not limited to:  ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites  establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs  proactively identifying and communicating issues impacting delivery and providing proposed solutions.  attending regional/area start up calls and providing input for assigned sites/studies  collection of essential documents from sites and completing quality check (ALCOA)  compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting  coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation ...