Alexis Pitts Email and Phone Number

-Perform tasks related to supporting operational strategy, planning, and execution of clinical studies-Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness in accordance with established protocols-Responsible for internal and external meeting planning, coordination, outcome documentation, and related follow up, Prepare presentation material for meetings, newsletters, and websites-Liaise with study Functional Leads and follow up on any outstanding actions, discuss risk, and develop a plan to ensure timely receipt of deliverables-Work with project team to set up and maintain project schedule. Update timelines within MS Project, CTMS, project governance tool, and other trackers, escalate when timelines are at risk-Assist with (timesheet vs budget) reviews ensuring project stays within allocated budget; vendor financial tracking & reconciliation; sponsor contract financial tracking & reconciliation; and final project financial reconciliation-Conduct Contract vs Study Plan Review, maintain tracker of out-of-scope work performed, Assist the Project Lead to create Change Order Forms and purchase orders, provide vendor management including reviewing of vendor invoices and tracking spending versus budget-Support the setup, maintenance, and closeout of Trial Master File, ensure TMF Reviews are being conducted as scheduled and TMF issues are resolved. Work with Project Lead to prepare the TMF for an audit/inspection-Creation of first draft project plans and first round draft revision for project plans ensuring template and version compliance-Support the study team to identify, prevent and close quality compliance gaps, Support the Project Lead to prepare for audits and/or investigations, including creation of story boards to document issues that may occur during the study, Support study team to ensure timely closure of audit/inspection CAPAs