University of Pennsylvania - Philadelphia, PA

posted 4 months ago

Full-time - Mid Level
Philadelphia, PA
Educational Services

About the position

The Program Manager B position at the Abramson Cancer Center (ACC) of the University of Pennsylvania is a pivotal role that involves overseeing the clinical research portfolio for the ACC CRU-Airways Research Team. The ACC is renowned for its innovative clinical trials aimed at improving cancer care, and the Program Manager will play a crucial part in advancing this mission. This role requires a comprehensive understanding of clinical research processes, as the Program Manager will be responsible for managing the start-to-end processes of study start-up and ongoing management. This includes assisting with study feasibility, selection, and prioritization of the team's work, as well as collaborating closely with regulatory coordinators to ensure timely activation and enrollment of trials. The Program Manager will work directly with the Physician Leader of the ACC CRU-Airways Research Team and will also report indirectly to the Manager of Clinical Research Operations. The successful candidate will actively manage ongoing research projects, troubleshoot operational issues, and assist with various aspects of the team's work, especially during periods of high workload or staff absences. This includes managing the research team’s protocol portfolio, which encompasses budgets, patient visits, data entry, and query resolution. In addition to overseeing clinical trials, the Program Manager will collaborate with both internal and external stakeholders to develop project plans and support the day-to-day operations of clinical research proposals. This role will involve monitoring patient recruitment and enrollment, ensuring adherence to protocol requirements, and maintaining all necessary documentation. The Program Manager will also be responsible for supervising clinical research staff, conducting regular meetings to review study statuses, and addressing any outstanding issues. The position requires a strong commitment to patient safety, protocol compliance, and data quality, adhering to the standards set by the University of Pennsylvania, GCP, FDA, and other regulatory bodies. The Program Manager will also assist in the development and maintenance of study-specific documentation and will be involved in various regulatory activities, budget development, and data management tasks.

Responsibilities

  • Oversee all aspects of the clinical research portfolio for the ACC CRU-Airways Research Team.
  • Manage the start-to-end processes for study start-up and ongoing study management.
  • Assist with study feasibility and selection, prioritization of the team's work.
  • Collaborate with regulatory coordinators to ensure competitive activation and enrollment timelines.
  • Actively manage ongoing research projects and troubleshoot operational issues.
  • Supervise clinical research staff including nurses, coordinators, and assistants.
  • Conduct regular meetings with team members to review study statuses and address outstanding issues.
  • Work with internal and external stakeholders to develop project plans and support clinical research operations.
  • Monitor patient recruitment and enrollment according to protocol requirements.
  • Ensure adherence to protocol requirements and maintain necessary documentation.

Requirements

  • Master's degree and 3-5 years of related experience or an equivalent combination of education and experience required.
  • Oncology clinical research experience preferred.
  • Effective problem-solving abilities.
  • Strong communication and writing skills.
  • Excellent organizational and time management skills.
  • Ability to work as part of a team and independently.
  • Knowledge of IRB and human research protection regulations.

Nice-to-haves

  • Experience with electronic Clinical Trials Management Systems (CTMS).
  • Familiarity with budget development for clinical trials.
  • Previous supervisory experience in a clinical research setting.

Benefits

  • Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
  • Tuition assistance for employees and their dependents.
  • Generous retirement plans including Basic, Matching, and Supplemental options.
  • Substantial time away from work for personal needs.
  • Long-term care insurance options for faculty and staff.
  • Wellness and work-life resources to support health and balance.
  • Professional and personal development resources.
  • Access to university resources and cultural activities.
  • Discounts and special services for faculty and staff.
  • Flexible work hours and options for non-traditional work arrangements.
  • Adoption assistance for eligible employees.
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