Clinical Project Manager

Key Activities and Responsibilities

  • Responsible for efficient implementation, execution and reporting of assigned clinical projects in accordance with protocol, timelines, and approved budget
  • Review of protocols and other essential documents (e.g. CTR, IB, DSUR)
  • Develop and/or contribute to the development of project specific procedures, manuals and instructions
  • Participate in preparation, tracking and forecasting of milestones and project budgets
  • Manage the preparation and update of project plans, key documents or tools (e.g. ICF, eCRF, eTMF)
  • Coordinate logistics of project materials and ensure timely provision to sites (e.g. IMP, laboratory kits)
  • Coordinate [ST(a1] feasibility study, site selection and initiation process
  • Ensure appropriate training of involved CRO personnel and the consistent use of project specific tools and procedures
  • Manage the efficient operational day-to-day activities of clinical projects and ensure protocol and ICH-GCP compliance
  • Supervise CRO/vendor performance
  • Define, track and report metrics (e.g. schedules, milestones, critical path) to provide continual visibility of status and deliverables
  • Identify and manage potential recruitment or operational issues - assist in problem resolution efforts such as protocol amendments
  • Identify quality issues early and escalate findings and develop/implement corrective action plans in close alignment with Quality Assurance
  • Ensure through efficient site management that data is entered into eCRF according to visit schedule
  • In close alignment with Data Management supervise the complete data management process
  • Supervise setting, maintenance and regular quality control of the eTMF

Required Education and Skills

  • Master's degree or PhD in a scientific or health-related field
  • Minimum 5+ years’ CPM experience with leading global oncology trials (phase I-III) and multi-functional teams
  • Demonstrated leadership and project management skills - experience in managing CROs is a plus
  • Extensive operational clinical trial management know how including startup, maintenance & close out
  • Strong organizational skills and communication abilities
  • Advanced understanding of GCPs and ICH guidelines
  • Fluency in English (verbal and written)
  • Position is based in Prague

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