Clinical Research Program Manager

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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.

Job Description

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***

Qualifica