Clinical Research Program Manager

University of Pennsylvania Perelman School of Medicine

1d•$75,804 - $81,441•Onsite

About The Position

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 a clinical trial, which includes assisting with recruitment, patient visits, blood draws, documentation, data entry, and IRB submissions. They will directly manage the research team (2 data analysts whose hiring is expected plus part-time and student workers , 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. Position contingent to funding

Requirements

Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience.
Strong organizational skills.
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.
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.
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.
Excellent organizational and time management skills.
Demonstrated ability to effectively present complex information is required.

Nice To Haves

Master’s degree in a health-related discipline plus 3-5 years relevant clinical research experience preferred.
Hematology/oncology, immunology, clinical trial, and registry study experience is preferred.
Experience conducting studies in one or more of the above content areas preferred.
Additional experience in clinical research is a plus.

Responsibilities

Oversees all Castleman disease (CD) clinical research programs, including the CD ACCELERATE natural history registry and CD biobank, Castlebank.
Key to the strategic planning and establishment of the CSTL, integrating clinical, research, educational and patient advocacy operations.
Engaged in the oversight of data acquisition and research execution of the ACCELERATE natural history registry and biobank studies.
Ensures protocols, SOPs, regulatory guidelines, GCP, and all best practices are followed rigorously.
Works closely with internal and external stakeholders to ensure regulatory compliance, completion of project milestones, reporting requirements, and correct allocation of resources.
Manages oversight of a clinical trial, including assisting with recruitment, patient visits, blood draws, documentation, data entry, and IRB submissions.
Directly manages the research team (2 data analysts, part-time and student workers, one registry coordinator, and one biobank assistant).
Participates in the quality auditing and database management of ACCELERATE and Biobank studies.
Manages the database, performs quality auditing and adverse event reporting.
Works with the UPenn IRB and foreign Ethics Committees in accordance with protocol requirements.
Coordinates the preparation and submission of regulatory documents (including continuing reviews, amendments, and adverse event reporting) to the IRB and other regulatory institutions.
Helps with the orientation, training and supervision of data analysts, coordinators, and student workers.

Benefits

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.
Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars.
Tuition assistance for employee, spouse, and dependent children at Penn and potentially other institutions.
Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth options and investment choices through TIAA and Vanguard.
Substantial amount of time away from work (vacations, personal affairs, illness, injury, family time).
Long-Term Care Insurance (optional, with underwriting requirements for family members).
Wellness and Work-life Resources.
Professional and Personal Development resources.
Access to a wide range of University resources, cultural and recreational activities (libraries, athletic facilities, arboretum, art galleries, museums, performance centers).
Discounts and special services (arts and entertainment, transportation, mortgages, new cars, cellular phone service plans, movie tickets, theme parks).
Flexible Work Hours.
Penn Home Ownership Services (forgivable loan for eligible employees in West Philadelphia).
Adoption Assistance (reimbursement for qualified expenses up to two adoptions).