Clinical Research Program Manager

Clinical Research Program Manager

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.

Qualifications

Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required.

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.

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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$75,804.00 - $81,441.00 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, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.