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

Medical University of South Carolina•Charleston, SC

1d•$81,192 - $146,166

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 evaluates new tuberculosis diagnostic technologies across domestic and international research sites. The role oversees study operations, coordinates activities among consortium partners, manages project timelines and budgets, and ensures compliance with research protocols and regulatory requirements. It requires periodic international travel, independent decision-making, and a high degree of professionalism.

Requirements

Bachelor's degree.
Four years of relevant program experience.
Ability to travel internationally periodically.
Ability to make independent decisions and demonstrate a high degree of professionalism.
Ability to perform the physical functions described in the posting, including frequent sitting, standing upright, walking or mobility, use of both hands and arms, and lifting or carrying up to 15 pounds infrequently.

Responsibilities

Provide overall program management for the FEND-TB Consortium and its domestic and international study sites, including managing the portfolio of tuberculosis diagnostic tests, forecasting workload, and integrating consortium teams and workflows.
Communicate with technology holders whose products are being evaluated, including coordinating timelines, results, and evaluation plans and managing expectations.
Work with consortium principal investigators to develop and revise strategy, and participate in selecting technologies and clinical study sites for evaluation.
Manage inter-institutional relationships, ensure clinical study work aligns with budgets at partner sites, and address issues or disagreements between sites.
Supervise study-specific training for international site teams, including on-site and remote training.
Work with the FEND-TB MUSC principal investigator, Rutgers principal investigators, and Rutgers administrative team to forecast and manage project expenses in relation to study and enrollment progress.
Supervise submission of FEND-TB protocols to regulatory offices; coordinate communications with U.S. study sponsors and regulatory agencies; and consult with international partners on country-specific ethics approvals.
Supervise processes for monitoring study quality and progress, ensure procedures are implemented and followed across sites, and work with international investigators and teams to identify and resolve issues. This includes periodic international travel and regular telephone or Skype communications.
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 regulations and MUSC IRB regulations.
Assist with grant proposals and progress reports and prepare and disseminate study results.
Perform other duties as assigned.