RESEARCH PROJECT MANAGER

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

NITRO Research Project Manager

Occupational Summary

The Research Project Manager will be approved by ARPA-H and will perform key duties throughout the NITRO (Novel Innovations for Tissue Regeneration in Osteoarthritis) project. This position is full-time, 100% grant-funded, and dedicated to the project.

The ideal candidate will be responsible for managing the access aspects of a federally funded, multi-center regenerative medicine program focused on osteoarthritis. This position will oversee clinical needs, access to therapy, balanced enrollments in translational and clinical research, and collaborate with other NITRO teams to create frameworks for treating osteoarthritis. The role includes assisting in the development of clinical and commercialization strategies. Additionally, this role will serve as the primary liaison between the project team, stakeholders, and the funding agency in the area of access.

The Research Project Manager will ensure that all performers follow the FDA’s guidance and that clinical trial populations reflect the same U.S. population proportions and severity as those affected by osteoarthritis.

In NITRO Phase 2, the officer will analyze the data from 8 demographic-specific listening sessions, prepare the “Road Map” report, finalize the Insurance Action Plan (with CMMI, CMS, and HHS engagement), co-manage and publish the proceedings of the Symposium, enforce prior KPIs, and implement the Clinical Trial Go/No-go Demographic Requirements, as described below.

The Project Manager will develop rollout strategies, engage stakeholders with the help of ARPA-H’s XIR/EIR network, and pursue all available approaches to ensure access throughout study designs and clinical trials across all therapeutic areas.

Work Performed

Develop KPIs and Analyze Data from Listening Sessions

• Refine and maintain KPIs
• Conduct qualitative and quantitative data analysis from 7-8 demographic listening sessions
• Prepare the "Road Map" report integrating feedback

Finalize the Insurance Action Plan

• Liaise with CMMI, CMS, HHS, and the Duke Margolis Center for Health Policy to review disease burdens and policy proposals for osteoarthritis
• Develop strategies for access and reimbursement considerations

Co-Manage Symposium

• Plan and implement the Symposium in collaboration with Duke REACH and UCLA

Enforce KPIs in Clinical Trials

• Develop rollout strategies for community engagement
• Create targeted strategies for all communities that are affected by osteoarthritis
• Work with clinical trial management to monitor KPI adherence
• Navigate the regulatory landscape with oversight (IRB and/or FDA)
• Adjust recruitment plans based on demographic data

Supervision

The Project Manager will be responsible for overseeing and managing employees across multiple locations nationwide, ensuring consistent performance, effective communication, and alignment with organizational goals. This includes providing leadership, coordinating workflows, addressing operational challenges, and fostering a productive and collaborative wor