.**Purpose**:The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.- Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads_**Primary responsibilities**:- Ensure 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- Establish 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 identify and communicate issues impacting delivery and providing proposed solutions.- Attend regional/area start up calls and providing input for assigned sites/studies- Collection of essential documents from sites and completing quality check (ALCOA)- Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting- Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements- Collaborate with contract manager, CRA, Area CSM Lead as required to assure timely site activation- Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas- Trigger clinical supply shipments- Complete IP release activities and triggering IP shipment- Issue site green light letter and activating sites in IXRS- Track all start up and maintenance related activities in Vault SSU as appropriate- Maintain local country and site intelligence database and EDLs in Vault.- Maintain SSU performance metrics and KPIs for assigned sites/studies.- Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads- Ensure audit/inspection readiness- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines- Participate in process improvement initiatives as required**Qualifications**:- Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.- Experience working with remote/virtual teams- Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.- Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements