Temp - Proj Manager A

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penns distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of Americas Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. Posted Job Title Temp - Proj Manager A Job Profile Title Temporary Employee - Non-Exempt Job Description Summary Candidate will work closely with Physician leaders to provide high-level research project management services and oversee all aspects of the clinical research portfolio being performed for their research program. This includes highly complex hypertension/renal denervation studies, PKD, transplant, and other renal studies within the Renal, Electrolyte, and Hypertension Division. Studies may include any combination of: investigator-initiated, multi-center, industry sponsored, registry, or other patient oriented clinical and translational research projects. He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, budget development and negotiation, interacting with funding administrators and the University Business office approval of both sponsored and internally-funded clinical research budgets to submitting for IRB closeout and archival of study files. He/she will be working closely with the junior staff to mentor manage, train, review and initiate trials to ensure competitive activation and enrollment timelines. He/she is expected to troubleshoot operational issues on a daily basis, identify problems and develop solutions, and assist with any and all aspects of their teams work during absences or when a specific team members workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budgets, research billing, patient visits, transporting specimens, data entry, query resolution, monthly invoicing, and working with study monitors). They will enforce strong record keeping, ensure data integrity, collection/storage, tracking protocols, and supervise staff in regulatory affairs. Additionally, he/will be responsible hiring, training, and evaluating direct reports from junior staff. Candidate will be expected to oversee all regulatory related work across ~30 studies, including but not limited to: submit local and central IRB submissions, maintain electronic and physical investigator site files, and maintain staff training qualification documents. He/she will be expected to communicate with sponsors, medical monitor, IRB, and other stakeholders regarding safety and deviation reporting; he/she will show vigilance in patient safety, protocol compliance, and data quality; and adhere to all University of Pennsylvania, IRB, and FDA guidelines. He/she may implement approved changes to procedures (CAPA) as needed and monitor results in addition to creating guidelines for standardizing internal procedures. Other duties include: AE/SAE reporting and escalation, research billing review in both EPIC, participate in sponsor/OCR/FDA monitoring and audits; submission to local and central IRBs (Advarra, WIRB, etc.), and submit RBN requests and PRAs to business office. May require working off site and flexible hours. The Program Manager position will directly report to Director of Clinical Research. A high level of independence, attention to detail, and strong communication skills are expected. Job Description 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. Position contingent upon funding Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $7.25 - $34.11 Hourly Rate Salary offers are made based on the candidates qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the jobs level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements A background check may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job. University Benefits Health and Life: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your familys health and welfare. Retirement: Penn offers generous retirement plans to help you save for your future. Penns Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard. Please note that benefit eligibility is determined/based on ACA guidelines. The University of Pennsylvanias special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the Universitys commitment to excellence in teaching, research, and scholarship. The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state or local law.