NJ Employer Clinical Trial Head in East Hanover, New Jersey

241470BR Clinical Trial HeadJob DescriptionAs the leader of the cross-functional clinical trial team, leads planning and management of the assigned clinical trials end-to-end to achieve Oncology Medical Affairs (OMA), Global Medical Affairs (GMA), GMA Franchise, Global Clinical Team (GCT) and Clinical Trial Team (CTT) objectives. Oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within disease area. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial(s).Major Accountabilities1.Lead and manage the global cross-functional CTT to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings related to clinical trials; chair the routine CTT meetings, report study progress and issues/resolution plan at the Global Clinical Team (GCT). Core member of the GCT.2.Lead the development of global clinical trial protocol(s) by translating the approved trial concept sheet(s) into efficient, high quality, executable clinical protocols:*Responsible for integrating and authoring clinical trial protocol(s) and related documents (e.g. informed consent) in collaboration with the Global Medical Director, the CTT members and the Novartis Country Pharma Organizations (CPOs)*Submit clinical trial protocol(s) to internal review board for approval;*Lead the development of scientific trial related documents (e.g. charters, scientific training material) with input of the of the Global Medical Director, and other line functions (e.g. data management, statistical analysis, etc.) as needed*Organize and participate in trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).*Collaborate with the Global Medical Directors and Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.3.Trial planning, execution and close-out:*Oversee trial feasibility and site selection process in collaboration with Trial Monitoring organization*Ensure all required documentation is provided to each participating country for Health Authority (HA) and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) submissions*Conduct investigator meetings/trainings in collaboration with the Novartis CPOs. Provide study specific training for Novartis CPOs and Regions*Responsible for ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)*Forecast and manage drug supply for Novartis and comparator drug products in collaboration with internal stakeholders*Develop clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); manage interface with CROs in cooperation with outsourcing management and line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts;*Contribute to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer*Create and drive trial level timelines*Create and execute an operational risk management plan highlighting potential risks and actions*Support implementation of global recruitment plan including contingencies in collaboration with Trial Monitoring*Manage and oversee resolution of trial operational issues*Provide updates on trial progress to relevant boards*Provide oversight on quality and compliance for assigned clinical trial(s) in conjunction with Medical Business Operations and Functional Excellenc