Clinical Research Program Manager B (Abramson Cancer Center) at University of Pennsylvania

University of Pennsylvania - Philadelphia, PA

Full-time - Mid Level

Philadelphia, PA

Educational Services

About the position

The Clinical Research Program Manager B position at the Abramson Cancer Center (ACC) of the University of Pennsylvania is a pivotal role that involves overseeing the Cell Therapy & Transplant Research Team within the Clinical Research Unit (CRU). The ACC is renowned for its innovative clinical trials aimed at improving cancer care, and this position is integral to advancing the science of cancer treatment. The Program Manager will report directly to the Director of Clinical Research Operations and will work closely with various stakeholders, including the CTT Physician Leader and the ACC CRU Central Manager of Clinical Research Operations. In this role, the Program Manager will be responsible for managing the entire clinical research portfolio, which includes overseeing study start-up processes, ongoing study management, and ensuring compliance with regulatory requirements. The successful candidate will assist in study feasibility assessments, prioritize team workloads, and collaborate with regulatory coordinators to ensure timely activation and enrollment of clinical trials. The Program Manager will also troubleshoot operational issues, manage research team protocols, and coordinate patient visits and data management activities. The position requires a proactive approach to managing ongoing research projects, including recruitment and enrollment of patients, monitoring adherence to protocol requirements, and maintaining comprehensive documentation for sponsors and CROs. The Program Manager will also be involved in developing project plans, supporting day-to-day operations, and ensuring that the CTT Research Program effectively serves the diverse patient population under study. This role is essential for maintaining high standards of patient safety, protocol compliance, and data quality, adhering to the guidelines set forth by the University of Pennsylvania, GCP, FDA, and other regulatory bodies.

Responsibilities

• Oversee all aspects of the clinical research portfolio for the Cell Therapy & Transplant Research Team.
• Assist with study feasibility and selection, prioritization of the team's work.
• Manage, review, and initiate trials to ensure competitive activation and enrollment timelines.
• Actively manage ongoing research projects and troubleshoot operational issues.
• Assist with managing the research team protocol portfolio including budgets, patient visits, and data entry.
• Work closely with internal and external stakeholders to develop project plans and support clinical research proposals.
• Recruit and enroll patients according to protocol requirements.
• Schedule patient visits and necessary testing, monitor patients per protocol requirements.
• Organize and maintain all documentation required by the sponsor or CRO.
• Collect, review, and report study data, complete case report forms, and resolve data queries.
• Participate in initiation, monitoring, audit, and close-out visits.
• Coordinate study team meetings and ongoing protocol training/compliance meetings.
• Supervise clinical research staff including recruiting, interviewing, hiring, and performance management.
• Conduct regular meetings with team members to review study statuses and troubleshoot issues.
• Facilitate the initiation of new trials from feasibility review to activation, including tracking protocols and budgets.

Requirements

• Bachelor's degree in a related field; advanced degree preferred.
• 5+ years of experience in clinical research management, preferably in oncology.
• Strong knowledge of GCP, FDA regulations, and clinical trial processes.
• Proven ability to manage multiple projects and prioritize tasks effectively.
• Excellent communication and interpersonal skills to work with diverse stakeholders.
• Experience in supervising and managing research staff.

Nice-to-haves

• Certification in Clinical Research (e.g., ACRP, SOCRA).
• Experience with electronic data capture systems and clinical trial management software.
• Familiarity with budget management and financial oversight in clinical trials.

Benefits

• Competitive healthcare benefits for employees and their families.
• Generous retirement benefits.
• Wide variety of professional development opportunities.
• Supportive work and family benefits.
• Health and wellness programs and resources.