UNIV - Program Manager II - Department of Medicine: Division of Infectious Diseases

20% Provide overall program management for the FEND-TB Consortium of international and domestic study sites. This includes management of the portfolio of TB diagnostic tests entering evaluation, forecasting and managing overall Consortium workload to ensure efficiency and progress, and ensuring integration of multi-country Consortium teams and workflows.

15% Work directly with technology holders whose products are being evaluated by FEND-TB to ensure seamless communications and manage expectations. This includes communicating around timelines, results, and overall evaluation plans.

10% Work directly with the FEND-TB Consortium PIs to develop and revise, as needed, consortium strategy for successfully accomplishing its mission. This includes active participation in the selection of technologies for evaluation as well as clinical study sites.

10% manage inter-institutional relationships for the international FEND-TB Consortium. This includes ensuring that clinical study work is aligned with allotted budgets at multiple partner sites and addressing issues and disagreements that may arise between sites.

10% - Supervise study-specific training for international site teams. This may include on-site trainings at the international study sites and/or remote (e.g. web-based) training.

10%- Work closely with the FEND-TB MUSC PI, Rutgers PIs, and Rutgers administrative team to forecast and manage project expenses as they relate to study/enrollment progress.

5% - Supervise FEND-TB protocols for submission to the necessary regulatory offices; manage and coordinate communications with study sponsors and regulatory agencies in the U.S. Provide consultation to international partners as they submit FEND-TB protocols for country-specific ethics approvals.

5% - Supervise FEND-TB consortium processes for monitoring study quality and progress. Oversee that processes are being implemented and adhered to among all sites. This will require periodic international travel to study sites as well as regular telephone/skype communications with international study teams. The Program Manager will work with international site investigators and teams to identify and resolve issues, should they arise.

5% Supervise the development and revision, as needed, of FEND-TB consortium procedure manuals and case report forms used during study implementation.

5% - Maintain appropriate certifications and credentials. Conduct all research in adherence with the FDA Code of Federal Regulations "Good Clinical Practices" as well as MUSC IRB regulations

5% - Other duties as assigned which includes assistance with grant proposals and progress reports, preparation and dissemination of study results.

Additional Job Description

Minimum Requirements: A bachelor's degree and four years relevant program experience.