Clinical Trials Regional Project Manager

hace 1 mes


Buenos Aires, Argentina 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. The successful candidate will be responsible for coordinating activities of project teams, ensuring milestones are met, and ensuring consistency of Clinical Operations processes across regions.

Key Responsibilities:

  • Coordinate project team work, 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 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.

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.

Additional Information:



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