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The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
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Posted Job Title
Program Manager (Cancer Center)
Job Profile Title
Manager Research Project B
Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 13 Research Teams that support disease/discipline specific cancer programs within the ACC. This Program Manager will have oversight of the ACC CRU- Lymphoma Research Team.
The Program Manager position will directly report to the Lead Nurse & Study Team Manager - Lymphoma Research. The successful candidate will work closely with the Physician leaders and (his/her designee) of this CRU Research Team to oversee all aspects of the clinical research portfolio being performed for their research program. 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, prioritization of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive activation and enrollment timelines. The Program Manager is expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors).
The Program Manager will work closely with major internal (PI, CRU Central - Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team. The Program Manager will work with Investigators and data informatics teams/programs to ensure the Lymphoma Research Program is supporting the patient population they are studying.
The Program Manager for the CRU Lymphoma Research Team will oversee Phase I-IV clinical trials. Additional activities may include recruitment, and enrollment of patients according to protocol requirements for their team. He/she may schedule patient visits and any necessary testing, monitor patients per protocol requirements and ensure adherence to protocol requirements, organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. He/she may collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings. The Program Manager will assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality.
Adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.
THIS POSITION IS CONTINGENT UPON FUNDING
Job Description
Specific responsibilities include (but are not limited to):
Recruit, interview, and hire non-licensed research staff (e.g., Coordinators, Data Managers, etc.). Maintain an instructional plan for all new hires, which includes training documentation as well as the establishment of performance and/or competency standards. Oversee and actively participate in Program-based training. Coordinate the involvement of experienced research staff as mentors.
Perform initial and ongoing personnel review and evaluation processes. Provide additional support by creating a framework of educational services and opportunities that promote professional growth and development. Measure performance, outcomes, and employee satisfaction and use the data from these metrics to produce actionable feedback Perform initial and ongoing personnel review and evaluation processes. Provide additional support by creating a framework of educational services and opportunities that promote professional growth and development. Measure performance, outcomes, and employee satisfaction and use the data from these metrics to produce actionable feedback
In support of the Program (i.e., therapeutic and non-therapeutic), serve as the primary site contact for funded research opportunities. This includes scheduling pipeline presentations, coordinating CDAs, and planning internal feasibility discussions. For studies entering start-up, this includes: completing FQs; scheduling and participating in PSSVs; receiving, collating, and verifying essential documents; coordinating the completion of internal cover sheets, tools and forms; securing signatures and forwarding documents to appropriate destinations.
Provide specialized and advanced support to IITs (this includes multi-site projects where HUP is the lead site) by assuming a "Sponsor role" which includes, but is not limited to: organizing IND applications, serving as the FDA liaison, coordinating activities across cross-functional team, reviewing and contributing to core study documents, qualifying vendors, developing and conducting training sessions, managing timelines and ensuring project milestones are met, monitoring data, overseeing reportable event pathways, coordinating CAPA plans through to resolution, and maintaining the TMF.
Develop and manage the Coordinator-led clinical trials program. This includes identifying qualifying clinical trials based on acuity, investigational product, and enrollment status, and close monitoring of Coordinators functioning in a dual role (i.e., without a nurse counterpart).
Create balanced and equitable study assignments, back-up systems, and coverage plans that take into consideration study acuity, workload, and experience. Expected to understand the full complement of duties typically assigned to direct reports and to fully execute these tasks as needed to ensure consistent and smooth implementation of daily operational procedures (e.g., managing study visits, facilitating exceptions, submitting reportable events, processing and shipping biological specimens, data entry, etc.).
Participate in quality assurance processes related to clinical trials including preparations for any inspection (e.g., internal and external audits). This involves reviewing Informed Consent forms, source documents, case report forms, monitoring letters and other essential documents for accuracy and completeness.
Provide a broad range of administrative support including dissemination of actively enrolling studies information, collating/routing amendment documents, updating recruitment platforms (i.e., Emerging Med, iConnect, ClinicalTrials.gov, etc.) as staff transitions occur, managing file archive and destruction, and following key metrics to measure the Program's overall health and performance. This also includes gathering and circulating basic information on research studies conducted outside of the Program but for which lymphoma patients may be eligible
Perform other duties as may be assigned
Qualifications:
Master's Degree with 3-5 years of related experience or equivalent combination of education and experience is required. Related experience in Oncology clinical research experience preferred
Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. And:
THIS POSITION IS CONTINGENT UPON FUNDING
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$59,703.00 - $95,524.33
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check 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, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn's 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.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay