PROGRAM MANAGER, SENIOR
Posting DetailsPosting Details Reference Number 40-31036 Posted Job Title PROGRAM MANAGER, SENIOR School Name Perelman School of Medicine Org CC-Cancer Center Posted to the Web 03/06/2019 Posted Job/Salary Grade 030 Employment Type Exempt Hours N/A Position Type Full Time Position Schedule 8am-5pm Months 12 Position Length Contingent Upon Funding Position End Date 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 Penn’s distinctive interdisciplinary approach to scholarship and learning.
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.
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.School/Center Overview
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/Duties
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. The Program Manager, Senior will have oversight of the ACC CRU- Cell Therapy and Transplant (CTT) Research Team.
The CTT Program Manager position will directly report to the Physician Leader of the ACC CRU- Cell Therapy and Transplant (CTT) Research Team and indirectly report to the CRU Central – Associate Director of Clinical Research Operations. The CTT Research Team supports the mission of the ACC, the Division of Hematology Oncology, the Center for Cellular Immunotherapy (CCI) and Penn Medicine to provide the most effective and innovative experimental cellular therapies (including BMT, CAR T cells, and immune factor cell therapies) to as many patients in need as safely as possible. The CTT Research Team Program Manager will have day-to-day central oversight of all CAR-T and transplant clinical research programs. The CTT PM will provide the coordinated management of the cell therapy and transplant research, for the Abramson Cancer Center & the University of Pennsylvania (including working with CRU Leukemia, Lymphoma, Myeloma Research Teams, and CCI/CTU Programs). The CTT PM will build an infrastructure that will work closely with the ACC Commercial CTT Program Leaders to coordinate efforts and manage commonly used transplant resources between commercial and research arms of the center.
The successful candidate will work closely with Physician leader of the CTT 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, Senior 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 Research Program is supporting the patient population they are studying.
The Program Manager for the CTT 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.
Specific responsibilities include (but are not limited to):
* Manage the day-to-day central oversight of all CAR-T and transplant clinical research programs. This will include coordinating the management of the cell therapy and transplant research, for the Abramson Cancer Center & the University of Pennsylvania (including working with CRU Leukemia, Lymphoma, Myeloma Research Teams, and CCI/CTU Programs). The CTT PM will build an infrastructure that will work closely with the ACC Commercial CTT Program Leaders to coordinate efforts and manage commonly used transplant resources between commercial and research arms of the center.
* Supervising the clinical research nurse(s), clinical research coordinator(s), and research assistants for the CTT team. This will include recruiting, interviewing, hiring, training, performance management, and paid time off for the staff. Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed
* Work with research team physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources in conjunction with available patient population statistics, anticipate any need for the group to hire additional staff based on data analysis and develop a business proposal to reflect any needs.
* Work with CRU Central to facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with sponsor to schedule SIV’s, and maintain communication with study teams and collaborative UPHS departments regarding progress.
* Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
* Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed to the Finance Office.
* Work closely with the Regulatory Coordinators of the CRU to manage review and startup of trials. Submit complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts.
* Work with team members to ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos), including study status, screening logs, serious adverse events and subject enrollment status. The Program Manager may also have primary study coordinator responsibility for at least 1 study.
* Closely monitor and report to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
SEE ATTACHED PIQ FOR CONTINUED POSITION SUMMARY
Master’s Degree and 5-7 year of related experience or an equivalent combination of education and experience required; or Bachelor’s Degree and 7-10 years of related experience or an equivalent combination of education and experience required. Oncology clinical research experience preferred. 5+ years of Good Clinical Practices (GCP) related experience required; Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired.
Prior experience with highly complex roles involving complex decision making and engagement of multiple departmental stakeholders; Able to confidently interact with all levels of management including senior management, physician leaders and others. Must be detail oriented and organized. Excellent verbal/written communication skills required. Prior experience in developing policy or procedural documentation, and or SOP is required. Excellent technical writing, review, and analytical abilities; Excellent interpersonal and multi-tasking skills. Ability to work collaboratively on all levels and to gain support of others. Ability to develop interdepartmental relationships and form solid collaborations is critical; strong knowledge of IRB and human research protection regulations. Demonstrated complex problem solving abilities; strong innovative skills, organizational skills, and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; Training and experience in clinical research or clinical research compliance healthcare required.
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. Quick Link http://jobs.hr.upenn.edu/postings/44106 Posting Supplemental Questions
Required fields are indicated with an asterisk (*).
- * How did you hear about this employment opportunity?
- [email protected]
- Contacted by a Penn Recruiter
- Referred by a Penn Employee
- Referred by a friend or family member
- Higher Education Recruitment Consortium (HERC)
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- * What is your highest level of education completed?
- Less than high school education
- High School Diploma or GED
- Vocational or Technical School
- Associate's Degree or Two Year College
- Bachelor's Degree
- Master's Degree
- PHD/MD/JD or equivalent doctoral degree
- * How many years of experience do you have related to this position?
- 0 to 1 Year
- 1 to 2 Years
- 2 to 3 Years
- 3 to 5 Years
- 5 to 7 Years
- 7 to 10 Years
- Over 10 Years
- * Do you have prior experience in developing policy or procedural documentation?
- * Do you have strong knowledge of IRB and human research protection regulations?
- * Do you have training and experience in clinical research or clinical research compliance healthcare?
- * Do you have thorough knowledge of relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines?
- Cover Letter