UNIV - Program Manager II - Department of Medicine: Division of Infectious Diseases
About The Position
Under the direct supervision of the Principal Investigator, the Program Manager II provides overall program management and coordination for the FEND-TB Consortium, which supports the evaluation of new tuberculosis diagnostic technologies across domestic and international research sites. The position oversees study operations, coordinates consortium partner activities, manages project timelines and budgets, and ensures compliance with research protocols and regulatory requirements. It requires independent decision-making, a high degree of professionalism, and periodic international travel. The role also supports consortium strategy, study-site and technology selection, partner relationships, training, financial forecasting, regulatory submissions, quality monitoring, and preparation of grant proposals and progress reports. Research must adhere to FDA Good Clinical Practices and MUSC IRB regulations.
Requirements
- Bachelor's degree.
- Four years of relevant program experience.
- Periodic international travel is required.
- Ability to perform the listed physical functions, including frequent standing/upright, seated, walking/mobile, hand and arm use, and fine motor activities; occasional lifting, carrying, pushing, or pulling up to 15 pounds; and work indoors continuously, with occasional outdoor work and work in confined spaces or dusty areas.
Responsibilities
- Provide overall program management for the FEND-TB Consortium and its domestic and international study sites, including managing the portfolio of TB diagnostic tests under evaluation, forecasting workload, and integrating teams and workflows.
- Communicate with technology holders about timelines, results, evaluation plans, and expectations.
- Work with FEND-TB Consortium PIs to develop and revise consortium strategy, including participation in selecting technologies and clinical study sites.
- Manage inter-institutional relationships and ensure clinical study work aligns with partner-site budgets; address issues and disagreements between sites.
- Supervise study-specific training for international site teams, including on-site and remote training.
- Work with the FEND-TB MUSC PI, Rutgers PIs, and Rutgers administrative team to forecast and manage project expenses in relation to study and enrollment progress.
- Supervise FEND-TB protocol submissions to relevant regulatory offices and coordinate communications with U.S. sponsors and regulatory agencies; consult with international partners on country-specific ethics approvals.
- Supervise consortium processes for monitoring study quality and progress and ensure they are implemented across sites.
- Travel periodically to international study sites and communicate regularly with international study teams; work with investigators and teams to identify and resolve issues.
- Supervise development and revision of consortium procedure manuals and case report forms.
- Maintain appropriate certifications and credentials and conduct research in accordance with FDA Good Clinical Practices and MUSC IRB regulations.
- Assist with grant proposals and progress reports and prepare and disseminate study results.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
