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Your Clinical Trial Deserves TLC From PRC

Clinical Project Manager

March 30, 2022

The Clinical Project Manager (CPM) assumes a primary role in the planning, implementation, execution and close out of assigned clinical trials commensurate with complexity and experience. The CPM directs, drives, and facilitates work across cross-functional teams to coordinate study related operational activities and assure timely attainment of trial milestones. This position is responsible for the operational planning for all phases of the study, including contributing to the clinical trial strategy, formulating timelines, forecasting and managing the overall study budget, developing risk management / contingency plans for minimizing impact on project objectives, site selection and management, monitoring, coordination of clinical data management and data analysis functions, CRO and vendor management.

Core Competencies:

  • Collaborates with and coordinates the activities of a large, diverse group of people who may be spread across multiple sites, countries, disciplines, and cultures
  • Thinks strategically and grasps the “big picture” of the clinical trials being overseen
  • Adapts to changing regulatory environments and unforeseen contingencies
  • Identifies solutions and predict outcomes
  • Utilizes Budget management and cost control measures
  • Highly detail oriented
  • Excellent verbal and written communication skills
  • Energetic, positive, flexible, team-oriented

Qualifications:

  • Bachelor’s Degree in a Scientific field or equivalent training or experience
  • 5+ years Clinical Research experience
  • Extensive working experience in conducting all phase clinical trials
  • Experience managing sites in large, multi-site clinical studies US and Ex-US preferred
  • Significant knowledge of FDA and ICH regulatory requirements, FDA guidance documents, etc.
  • General understanding of scientific and statistical principals, drug development process, clinical trial design and analysis/presentation/reporting of data collected in clinical trials

Job Types: Full-time, Part-time, Contract

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