Country Project Coordinator

vor 1 Woche

Zug, Zug, Schweiz PSI Vollzeit

Company Overview

We are PSI, a dynamic company that puts its people first.

Job Description

The Regional Project Lead plays a crucial role in managing and coordinating project activities in designated countries.

This individual ensures consistency of Clinical Operations processes across regions and meets study milestones through effective team management.

Key Responsibilities

  1. Ensure compliance with industry regulations, ICH-GCP, essential study documents, and controlled documents.
  2. Act as the primary or secondary project management contact for the project team and PSI support services.
  3. Perform study status reviews and progress reporting, if delegated by the Project Manager.
  4. Collect and report project status updates for designated regions, both internally and externally.
  5. Develop and update project planning documents, essential study documents, and project manuals/instructions.
  6. Manage and report on Key Performance Indicators (KPIs) for designated countries and clinical project team members.
  7. Ensure timely project timelines and subject enrollment targets are met in designated countries.
  8. Coordinate maintenance of study-specific and corporate tracking systems.
  9. Coordinate site contractual startup and budget negotiations.
  10. Establish communication lines within the project team and supervise clinical project team members' performance.
  11. Identify, escalate, and resolve resourcing and performance issues.
  12. Conduct and supervise therapeutic area training of the project team, if delegated by the Project Manager.
  13. Prepare presentations and conduct training of Investigators.
  14. Ensure team compliance with project-specific training matrix.
  15. Perform field training of Monitors tailored to the project needs.
  16. Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits.
  17. Oversee investigator and site payments, as well as CRF data retrieval/upload and monitoring and the query resolution process.
  18. Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings.
  19. Coordinate conduct of supervised monitoring visits.
  20. Review site visit reports and ensure monitoring and reporting standards are met.
  21. Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
  22. Oversee the safety information flow and participate in feasibility research.
  23. Review/approve project-related expenses and timesheets, if delegated by the Project Manager.

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