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Site Management Associate

hace 2 meses


Xico, México 520 Icr Mexico - Mex A tiempo completo

Job Summary

As a Site Management Associate at 520 Icr Mexico - Mex, you will be responsible for managing, implementing, and monitoring clinical studies within a global organization. This role involves working in a team setting to ensure the successful execution of clinical trials.

Key Responsibilities

  • Complete essential document collection and review throughout the study lifecycle, including site activation.
  • Manage the electronic Trial Master File for each site, performing periodic QCs and site level maintenance of the eTMF.
  • Update Clinical Management Systems, local regulatory tasks, protocol amendments, submissions packages, preparations for sites/ethics committees submissions.
  • Conduct remote site monitoring visits and/or targeted on-site visits as needed.
  • Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks.
  • Perform study tracking CTMS.
  • Act as primary site contact/liaison for study and site management issues, including addressing questions, managing study supplies, and conducting offsite central monitoring visits and contacts.
  • Escalate issues and risks as needed.
  • Provide training and mentoring to less experienced team members.
  • Act or assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management, and evaluation of metrics to identify process improvements.
  • Contribute to business development activities by participating in proposals and bid defenses.
  • Support manager and interface with partner departments to support enhanced project delivery.
  • May create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers.

Requirements

This role requires a strong understanding of clinical trials and site management processes. The ideal candidate will have excellent communication and organizational skills, with the ability to work effectively in a team environment.