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 Project Manager 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 work environment across all sites. The role will also involve monitoring performance metrics, implementing best practices, and ensuring compliance with company policies and standards at each location.

This requires the supervision of research and coordination of other researchers in patient-based projects in designated joint research locations (currently Los Angeles, Durham, and other cities per the project requirements) across the US.

Required Qualifications at this Level

Education
Requires a Bachelor's degree in a related field.

An advanced degree is preferred (i.e., MPH, MBA, MPP, MSW, etc.).

Experience
Minimum of four years of related experience.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills

• Excellent interpersonal and communication skills
• Ability to focus on strategic goals and implement appropriate interventions
• Progressive responsibility in program development or management in academia, not-for-profit, or business
• Development of faculty or staff programs is strongly preferred.

Duke is an Affirmative Action/Equal Opportunity Employer committed toproviding employment opportunity without regard to an indiv idual's age,color, disability, gender, gender expression, gender identit y, geneticinformation, national origin, race, religion, sex, sexual orie ntation,or veteran status.

Duke aspires to create a c ommunity built on collaboration,innovation, creativity, and belonging. O ur collective success depends onthe robust exchange of ideas—an exchange that is best when the richdiversity of our perspectives, backgrounds, a nd experiences flourishes.To achieve this exchange, it is essential that all members of thecommunityfeel secure and welcome,that the contribut ions of allindividuals are respected, and that all voices are heard. All members ofour community have a responsibility to uphold these values.

Anticipated Pay Range:

• Develop rollo ut strategies for community engagement
• Create targeted strategies for all communities that are affected by oste oarthritis
• Work with clinical trial manageme nt to monitor KPI adherence
• Navigate the reg ulatory landscape with oversight (IRB and/or FDA)
• Adjust recruitment plans based on demographic data
  • Excellent interpersonal and communication skills
  • Ability to focus on strategic goals and implement ap propriate interventions
  • Progressive responsibility in pro gram development or management in academia, not-for-profit, or business< /li>
  • Development of faculty or staff programs is strongly preferred.< /li>
• Duke U niversity provides an annual base salary range for thisposition as USD $ 0.00 to USD $0.00. Duke University considersfactors such as (but not lim ited to) scope and responsibilities of theposition; candidate's work exp erience, education/training, and keyskills; internal peer equity; as wel l as market and organizationalconsiderations when extending an offer.

   

  Your total compensation goes beyond the dollars on your payche ck.Duke provides comprehensive and competitive medical and dental carepr ograms, generous retirement benefits, and a wide array offamily-friendl yand cultural programs to eligible team members. Learn more at:https:// hr.duke.edu/benefits/

   

  Essential Physical Job Functions: C ertain jobs at Duke University andDuke University Health System may incl ude essential job functions thatrequire specific physical and/or mental abilities. Additionalinformation and provision for requests for reasonab le accommodation willbe provided by each hiring department.

   

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.