Clinical Research Operations Specialist

hace 2 semanas


Xico, México Icon A tiempo completo

Company Overview

At ICON, we are proud to be a world-leading healthcare intelligence and clinical research organization. Our mission is to shape the future of clinical development by fostering an inclusive environment that drives innovation and excellence.

About the Role

We are seeking a skilled Clinical Research Operations Specialist to join our team. As a key member of our global organization, you will be responsible for managing, implementing, and monitoring clinical studies in a team setting.

Your Responsibilities:

  • Manage electronic Trial Master Files (eTMFs) for each site, performing periodic quality controls and site-level maintenance.
  • Update Clinical Management Systems, perform local regulatory tasks, protocol amendments, and submissions packages preparations for sites and ethics committees.
  • Conduct remote site monitoring visits and/or targeted on-site visits as needed.
  • Manage payments, process Follow-Up Payments (FUP), Informed Consent Forms (ICFs) adaptations/reviews at site level, Ethics Committees annual renewals, progress/annual reports, site & study close-out related tasks.
  • Perform study tracking using CTMS.
  • Act as primary site contact/liaison for study and site management issues, including addressing questions, managing study supplies, and conducting off-site central monitoring visits and contacts.
  • Escalate issues and risks as needed.
  • Provide training and mentoring to less experienced team members.
  • Assist functional team leads in supporting sponsors, including 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.

What We Offer

In addition to your competitive salary of $60,000-$80,000 per year, depending on location and experience, we offer a range of benefits designed to support your well-being and work-life balance. These include various annual leave entitlements, a range of health insurance options, competitive retirement planning offerings, a Global Employee Assistance Programme, life assurance, and flexible country-specific optional benefits.

About You

To succeed in this role, you will need a Bachelor's Degree in Health Sciences or a related field, with +3 years of experience in a similar position. You should have in-depth knowledge of the drug development process, ethics committees, and MOH submissions. Advanced English language skills are mandatory, and monitoring/remote monitoring experience is recommended for Level I positions.



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