Medical University of South Carolina UNIV - Project Management Director DCU - Public Health Sciences (PHS) in Charleston, South Carolina
Job Summary: The Department of Public Health Sciences is currently recruiting for a Project Management Director. The Program Coordinator II will serve as the Project Management Director for assigned DCU studies.
Payscale Salary Range: UNIV-Band 6: $40,759.00 - $58,086.00 - $75,413.00 (min - mid - max)
25% - Serve as the Project Management Director for assigned DCU studies. Direct, implement, oversee, and manage all study specific project management activities for assigned projects. Provide comprehensive guidance and direction to collaborators pertaining to project management issues. - (Essential)
25% - Assess project management procedures with a focus on risk in accordance with the FDA policies and guidance on centralized monitoring and ICH Good Clinical Practice guidelines, and implement changes to ensure high quality trial conduct. - (Essential)
20% - Lead and direct the development of trial specific procedures related to Project Management activities and responsibilities. Coordinate the development and maintenance of study specific documents, including, protocols, informed consent forms, and manual of procedures. - (Essential)
10% - Review program objectives to determine compatibility with agency's mission; assess programs and propose policy or procedure changes. Provide direction and guidance to staff concerning program issues. Participate in the management of the assigned studies; attends planning sessions, recommend allocation of resources, provide feedback to employees and agency head. - (Essential)
10% - Prepare and present project management reports to the Operations Committee as well as sponsor and federal agencies as requested. Respond to requests for information from the PI and sponsor. - (Essential)
10% - Direct and oversee study drug distribution, safety reporting, the collection of regulatory and essential documents, and the activities of external site monitors. - (Essential)
Minimum Experience and Training Requirements: A bachelor's degree and two years relevant program experience.
Physical Requirements: 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 lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (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 perform gross motor functions with frequent fine motor movements. (Frequent)