Clinical Trial Manager

The Clinical Trial Manager (CTM) positionperforms as project lead for multiservice clinical trials (some global in scope). The position interacts with sponsors and manages the timeline and all project deliverables. This role coordinates all services contracted for the study. CTMs are also responsible for leading a team of CRAs and managing project coordinators.

• Effective Management of a project including:
  • Coordinate and manage project start-up, project maintenance, and project close-out activities;
  • Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
  • Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;
  • Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external);
  • Provide management oversight for Clinical Research Associates and Project Coordinators on project team;
  • Interpret contract-related issues and coordinate Medpace activities according to current scope;
  • Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;
  • Communicate change in scope to Sponsor clinical team and Medpace Contract Manager.
• Provide input for following (when applicable):
  • Study protocol
  • Edit Check Specifications
  • Data Analysis Plan
  • Data clean-up results
  • Analysis
  • Final study report

• Bachelor’s degree and 4 years related pharmaceutical industry experience (clinical monitoring or study management), or Master's degree/PhD with 2 years of related pharmaceutical industry experience (clinical monitoring or study management);
• Broad knowledge of medical terminology, clinical patient management, and clinical research methodology;
• Bilingual Japanese and English