Clinical Trials Regional Project Lead

hace 2 días

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

Job Title: Clinical Trials Regional Project Lead

Job Summary:

We are seeking a highly skilled Clinical Trials Regional Project Lead to join our team at PSI. As a key member of our Clinical Operations department, you will be responsible for coordinating project activities, ensuring milestones are met, and maintaining consistency of Clinical Operations processes across regions.

Key Responsibilities:

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

Requirements:

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

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