Posted in Other about 2 hours ago.
Clinical Research Program Manager
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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's 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.
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.
Posted Job Title
Clinical Research Program Manager
Job Profile Title
Clinical Research Program Manager B
Job Description Summary
Working in partnership with the Director of Clinical Research of the Center for Cytokine Storm Treatment and Laboratory (CSTL), the Program Manager oversees all Castleman disease (CD) clinical research programs, specifically including the CD ACCELERATE natural history registry and CD biobank, Castlebank. The Program Manager will be key to the strategic planning and establishment of the CSTL, which will integrate clinical, research, educational and patient advocacy operations. The Program Manager will be engaged in the oversight of data acquisition and research execution of the ACCELERATE natural history registry and biobank studies. The Program Manager will ensure that the protocols, SOPs, regulatory guidelines, GCP, and all best practices are followed rigorously. The Program manager will work closely with major internal (PI, data coordinators, researcher, laboratory technician, students, Institutional Review Board (IRB), etc.) and external (pharmaceutical collaborators, non-profit partners, external collaborators, oversight boards, CROs, Subcontractors, etc.) stakeholders to ensure regulatory compliance, completion of project milestones, and completion of all reporting requirements, and correct allocation of resources.
Job Description
Working in partnership with the Director of Clinical Research of the Center for Cytokine Storm Treatment and Laboratory (CSTL), the Program Manager oversees all Castleman disease (CD) clinical research programs, specifically including the CD ACCELERATE natural history registry and CD biobank, Castlebank. The Program Manager will be key to the strategic planning and establishment of the CSTL, which will integrate clinical, research, educational and patient advocacy operations. The Program Manager will be engaged in the oversight of data acquisition and research execution of the ACCELERATE natural history registry and biobank studies. The Program Manager will ensure that the protocols, SOPs, regulatory guidelines, GCP, and all best practices are followed rigorously. The Program manager will work closely with major internal (PI, data coordinators, researcher, laboratory technician, students, Institutional Review Board (IRB), etc.) and external (pharmaceutical collaborators, non-profit partners, external collaborators, oversight boards, CROs, Subcontractors, etc.) stakeholders to ensure regulatory compliance, completion of project milestones, and completion of all reporting requirements, and correct allocation of resources.
Strategic planning and oversight by the Program Manager will be critical to the successful establishment of the ACCELERATE Natural History Registry and Castlebank. It is essential that the Program Manager has experience with research planning, operations, and project management. Another important component of the Program Manager is managing oversight of the clinical trial, which includes assisting with recruitment, patient visits, blood draws, documentation, data entry, and IRB submissions. They will directly manage 4 members of the research team (2 data analysts, one registry coordinator, and one biobank assistant).
This position will also participate in the quality auditing and database management of ACCELERATE and Biobank studies. The Program Manager will also manage the database, perform quality auditing and adverse event reporting, and work with the UPenn IRB and foreign Ethics Committees in accordance with protocol requirements. The Program Manager will coordinate the preparation and submission of regulatory documents (including continuing reviews, amendments, and adverse event reporting) to the IRB and other regulatory institutions. They will help with the orientation, training and supervision of data analysts, coordinators, and student workers.
Qualifications
Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.
Master's degree in a health-related discipline plus three to five years relevant clinical research experience or an equivalent combination of education and experience is required. Hematology/oncology, immunology, clinical trial, and registry study experience is PREFERRED.
Strong organizational skills; experience conducting studies in one or more of the above content areas preferred; excellent verbal and written communication skills essential to enable working with multiple members of research team; must be highly skilled in MS Word and Excel applications, understand medical records/patient charts organization and terminology.
Strong management and leadership skills essential.
Additional experience in clinical research is a plus. The appropriate candidate will possess a thorough knowledge of Federal Regulations, GCP and IND/IDE in research. Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research. Position requires effective problem solving abilities; must be able to multi-task and prioritize; a strong work ethic; ability to work as part of a team, as well as independently; and excellent organizational and time management skills.
Demonstrated ability to effectively present complex information is required.
Position is contingent upon continued funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$61,046.00 - $89,789.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
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
Eurofins Lancaster Laboratories Professional Scientific Services, LLC |
American Cybersystems, Inc. |
Davidson Hospitality Group |