Clinical Trials Regional Project Coordinator

hace 1 semana

Bogotá, Bogotá D.E., Colombia PSI A tiempo completo

About this role:

As a Clinical Trials Regional Project Lead at PSI, you will play a key role in coordinating project teams and ensuring milestones are met while maintaining consistency of Clinical Operations processes across regions.

Key responsibilities:

  1. Coordinate project team work and supervise clinical project team members' performance.
  2. Implement and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.
  3. Act as a point of contact for the project team, PSI support services, and contractors.
  4. Collect and report project status updates.
  5. Develop and update project planning documents, essential study documents, and project manuals/instructions.
  6. Conduct and supervise therapeutic area training of the project team and Investigators.
  7. Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits, and review site visit reports.
  8. Oversee investigator and site payments.
  9. Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings.
  10. Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.

Requirements:

  1. College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
  2. Full working proficiency in Spanish and English.
  3. At least 4 years' experience in a healthcare or clinical environment.
  4. Minimum 4 years' site monitoring experience and at least 2 years' experience as Lead Monitor or equivalent.
  5. Availability to travel.
  6. Proficiency in MS Office applications.
  7. Ability to plan and work in a dynamic team environment.
  8. Communication, collaboration, and problem-solving skills.

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