Full-Time

Univ – Program Coordinator II: Project Management Director

Department of Public Health Sciences

Updated on 12/12/2024

Medical University of South Carolina

Medical University of South Carolina

Compensation Overview

$46.7k - $86.3kAnnually

Junior, Mid

Charleston, SC, USA

Category
Project Management
Business & Strategy
Requirements
  • A bachelor's degree and two years relevant program experience.
Responsibilities
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Direct and oversee study drug distribution, safety reporting, the collection of regulatory and essential documents, and the activities of external site monitors.
Medical University of South Carolina

Medical University of South Carolina

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