Clinical Study Manager

hace 1 semana

Xico, México 520 Icr Mexico - Mex A tiempo completo

About the Role

We are seeking a highly skilled and experienced Clinical Study Manager to join our team at 520 Icr Mexico - Mex. As a Clinical Study Manager, you will be responsible for managing, implementing, and monitoring clinical studies, with support, in a team setting within a global organization.

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, inclusive of protocol questions, managing study supplies, and conducting offsite central monitoring visits and contacts (pre-study, initiation, monitoring, and close out visits).
  • 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.
  • Also may create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers.

Requirements

  • Bachelor's Degree, preferable in health/sciences.
  • In-depth knowledge of the drug development process.
  • +3 years experience in similar position.
  • Knowledge about ethics committees and MOH submissions for protocols, amendments, investigator brochure, and ICFs.
  • In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.
  • Advanced English level (oral and written) – mandatory.
  • Monitoring/remote monitoring experience (recommended for level I - mandatory for senior).
  • Good leadership skills, advanced critical thinking, as well as strong organization, communication, and time management skills.

About Us

We want to be the Clinical Research Organisation that drives more client projects to market or accelerated decision than anyone else in the industry. In short, to be the partner of choice in drug development. That's our vision. We're driven by it. And we need talented people who share it.

What We Offer

  • Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
  • In addition to your competitive salary, we offer a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme.

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