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 requirements  collaborating 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  triggering clinical supply shipments  completing IP release activities and triggering IP shipment  issuing site green light letter and activating sites in IXRS  tracking all start up and maintenance related activities in Vault SSU as appropriate  maintaining local country and site intelligence database and EDLs in Vault.  maintaining SSU performance metrics and KPIs for assigned sites/studies.  providing start up updates and metrics to CCOM/COM and Area SSU and CSM Leads  ensuring audit/inspection readiness  ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines  participating 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.  Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment  Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment

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