The Scientific Program Manager is responsible for overseeing all operational aspects of the Center for Generative Immunotherapy (CGI). They will ensure optimal efficiency, productivity and quality of all preclinical research and clinical trial components; coordinate site performance reports for presentation to CGI Directors; and develop remediation and improvement strategies, as needed. This person will work with CGI research staff and collaborators to facilitate the accomplishment of the program aims and communicate progress and challenges towards meeting these aims. This person will also develop, review and edit project plans, monitoring progress to milestones to assure consistency with project goals while providing organization and facilitation of project administration, finances, communications, and meetings related to program activities (preclinical research and clinical trial study organization, initiation, execution, and closure). This person will also be responsible for coordinating compliance with institutional regulatory requirements (e.g. staff training, EHS certifications, IRB communications etc.). Assistance with experimental work including sample processing, QA/QC, T cell culture, and preparation of libraries for next generation sequencing may be occasionally required but is not a major part of the job.
Responsibilities may include but are not limited to: With the research team and collaborators (internal and external to UNC) develop and implement project plans and project management infrastructure (standard forms, operating procedures, dashboards). Coordinate the hiring and training of CGI staff. Facilitate communication between the collaborating partners including those responsible for laboratory experimentation and data management. Ensure that investigators, research staff, and external partners (e.g. collaborators, contract manufacturers, regulatory agencies) receive timely and accurate responses to program-related issues. Participate in the development and maintenance of written study documentation. Coordinate central training sessions. Collaborate internally in development and execution of data management systems for collection of clinical trial data in compliance with regulatory guidelines and preclinical experimental data in accordance with GLP guidelines. Develop specifications for data checks and monitor implementation. Develop specifications for analyses and tabulations for major study reports. Prepare written and/or verbal reports interpreting program data, including communications with the research sponsor. Work with Regulatory Team to maintain regulatory compliance including reports to the IRB, protocol amendments and modifications, and FDA communications. Provide oversight with the Directors of progress towards project milestones.