Site Operations Specialist II - Hybrid, Mexico City

ICON Clinical Research

Ciudad de México

Híbrido

MXN 500.000 - 700.000

Jornada completa

Hace 7 días
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Ventajas ofrecidas por este puesto de trabajo

Various annual leave entitlements
Health insurance offerings
Retirement planning options
Global Employee Assistance Programme (
Life assurance
Flexible country-specific benefits

Descripción de la vacante

ICON Clinical Research in Mexico City is seeking a Site Specialist II to independently manage site support activities and ensure efficient study start-up and maintenance. You will serve as a key operational contact for sites and help drive quality and productivity across trials.

The role emphasizes site activation, regulatory coordination, and collaboration with cross-functional teams in a hybrid work environment.

Formación

  • Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field, or equivalent experience in clinical research.
  • Experience in Clinical Research, Site Support, Study Start-Up, Clinical Administration, or similar functions within a CRO, pharmaceutical company, or healthcare environment.
  • Previous Study Start-Up experience is required, with preference for candidates who have supported U.S.-based clinical studies.
  • Strong organizational and project coordination skills, with the ability to manage multiple sites, timelines, and competing priorities simultaneously.
  • Strong written and verbal communication skills, with a proactive and customer-focused approach to stakeholder management.
  • Advanced English proficiency, including the ability to conduct meetings, prepare documentation, and interact effectively with international teams and study stakeholders.
  • Strong understanding of site activation requirements and ethics/IRB submission processes.

Responsabilidades

  • Coordinating site-level document collection, review, and maintenance, ensuring accuracy and compliance for assigned sites or studies.
  • Acting as an operational liaison for site staff on documentation, systems, and process-related questions.
  • Maintaining up-to-date site status, metrics, and key milestones in clinical trial management tools.
  • Supporting planning and logistics for site meetings, investigator meetings, and monitoring visits.
  • Identifying opportunities to streamline site workflows and contributing to process improvement initiatives.
  • Providing guidance to Site Specialist I or junior colleagues, sharing best practices and supporting their development.
  • Prepare and review site activation packages, ensuring all required documentation, approvals, and regulatory requirements are in place prior to site activation.
  • Coordinate the preparation, submission, and tracking of regulatory documentation for Ethics Committees/Institutional Review Boards (IRBs), including protocols, informed consent forms (ICFs), Investigator Brochures (IBs), and other study-related materials.

Conocimientos

Organizational skills
Project coordination
Stakeholder management
Communication skills
Advanced English

Educación

Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field

Descripción del empleo

ICON Clinical Research in Mexico City is seeking a Site Specialist II to independently manage site support activities and ensure efficient study start-up and maintenance. You will serve as a key operational contact for sites and help drive quality and productivity across trials.

The role emphasizes site activation, regulatory coordination, and collaboration with cross-functional teams in a hybrid work environment.

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