Clinical Trials Regional Project Manager

hace 4 semanas


Xico, México Psi Cro A tiempo completo

Job Summary

Psi Cro is a leading Contract Research Organization with a strong presence in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Key Responsibilities

  • Coordinate project team activities to ensure milestones are met and consistency of Clinical Operations processes across regions.
  • Supervise clinical project team members' performance and implement 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 Cro 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 resolve audit/inspection findings.
  • Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
  • Perform other project management tasks in agreement with the responsible Clinical Operations Manager following adequate and documented training, and formal delegation of tasks.

Requirements

  • College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
  • Full working proficiency in 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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