About this role
Job Description Summary
Under the direct supervision of the Principal Investigator, the Program Manager II will provide overall program management and coordination of the FEND-TB Consortium, supporting the evaluation of new tuberculosis diagnostic technologies across domestic and international research sites. This position will oversee study operations, coordinate activities among consortium partners, manage project timelines and budgets, and ensure compliance with research protocols and regulatory requirements. The position requires periodic international travel, independent decision-making, and a high degree of professionalism.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC000972 COM DOM Infectious Diseases CC
Pay Rate Type
Pay Range
81,192.00 - 113,730.00 - 146,166.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Job Duties:
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
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A bachelor's degree and four years relevant program experience.
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Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)
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If you like working with energetic enthusiastic individuals, you will enjoy your career with us!
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The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.
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Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees