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Posted Job TitleProject Manager A/B (Penn Infectious Diseases Clinical Research Unit)Job Profile TitleManager Research Project AJob Description SummaryThe Project Manager will provide staff oversight, project management, expertise, and administrative support for clinical trials in the Penn Infectious Diseases Clinical Research Unit consisting of projects in HIV, COVID-19, and other infectious diseases. Project Manager work includes overall management of research projects, supervision of research staff, regulatory submissions, recruitment strategy, study start-up, performance management, and development of key study documents including protocol, consent, and CRFs. The Project Manager will oversee expenditures and income, negotiate agreements with service providers, and interact with the business administration to ensure income is received and expenditures are paid. The position will also include participation in national organization meetings, as well as University department meetings and committees. The staff member will maintain skill levels through educational opportunities, sponsor trainings, attendance at conferences and communication with other providers.Job DescriptionThe Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Penn Department of Medicine Infectious Disease Clinical Trials Unit. The person will work closely with leadership to support investigators and coordinators, working on observational clinical research and clinical trials ranging from phase I-IV, investigator/industry-initiated, different disease states and varying complexities. Involvement will range from consulting to serving as the project manager for a study having primary responsibility with respect to execution and operational planning of the studies and accountability for results. The Project Manager will oversee the delivery of patient care as defined in the study protocols. The Project Manager will manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Sponsor, study team and in accordance with all regulatory organizations. S/he will play a key role in study start-up, intake & feasibility for many studies.
The Project Manager will provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance. S/he will generate study specific plans and documents, provide input and management of study budgets, and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. S/he will lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues. S/he will provide leadership and guidance to research personnel in their day-to-day operational activities. S/he will perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks. S/he will participate in documentation of best practices and SOPs.
The Project Manager will have close supervision from Director on projects, and will manage 1-2 staff.
Project Manager B will in addition to the responsibilities detailed above, the function autonomously as project manager on projects, including development and negotiation of study budgets, and will manage 2-4 staff.
***Position contingent upon funding***
Qualifications
Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem solving skills necessary. Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously. Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions. Flexibility and the drive to meet project deadlines required. Knowledge of regulatory processes required. Excellent written and verbal skills required.
PM A: A Bachelor's Degree and 3 - 5 years of related experience or an equivalent combination of education and experience required.
PM B: Mater's Degree and 3-5 years of related experience or an equivalent combination of education and experience required.
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