Charlotte, North Carolina, United States
Specialties: Renal, Inflammation, Oncology and CNS. Early Phase through Phase 3
Manage ROW Operations for Phase 3 MBC trial Manage direct report and mentor junior staff Management of CRO and vendors, including performance management, issue resolution and maintenance of budget/SoW Assisted in drug supply management, drug forecasting, and risk mitigation Plan, manage and present at global Investigator Meetings Lead cross functional team meetings
Manage two Phase III clinical trial(s) in Ophthalmology by working cross-functionally to ensure timelines and budgets are met Perform ongoing vendor management (CROs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, issue resolution, and quarterly visits Provide study-specific direction and mentoring to Global and Country Study Associates Provide support and mentoring to other Clinical Trial Managers, as appropriate Ensure trial adherence to ICH/GCP regulations Participate in clinical operations initiatives and programs (Lunch and Learn Panel, Fit For Purpose Monitoring, Communication Initiative, Process Optimization for Trial Documentation, Interview panel and Lead the System Migrations Team) Establish study milestones and ensure accurate tracking and reporting of study metrics Clinical Representative for successful NDA Oncology Filing Lead cross-functional Phase 1 and II study teams Perform study management over mulitiple projects from strart up to CSR Collaborate with clinical developement for protocol design, plan and execution Conduct site and vendor selection Complete RFPs, review proposals, faciliate negotiation, select and manage vendors Manage/create project timelines and budgets Provide drug supply assumptions to clinical planning team Partner with NextGen as a mentor for new to research employee Contribute to annual IND updates and IND submissions