Clinical Project Manager

New
Remote - USFull-TimeManager
Salary not disclosed
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Job Details

Required Skills
Project ManagementRisk ManagementData managementBudget management

Requirements

  • Bachelor's degree in science, nursing, other biomedical discipline, or equivalent
  • Clinical research experience as a CRA or Research Coordinator is preferred
  • Experience in support of business development processes; including budgets, proposals and bid defense planning and execution
  • Ability to work across multiple projects
  • Experience with renal and hepatic impairment, infectious disease and tobacco studies is an asset
  • Flexible and willing to travel up to 30% (regional)
  • Excellent problem-solving and decision making skills

Responsibilities

  • Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements
  • Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline
  • Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans
  • Coordinate activities with central laboratories and other external service providers/vendors
  • Review and negotiate site budgets and contracts
  • Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets
  • Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion
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