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Site Activation Manager

icon · Mexico City

Nuevo
Hybrid Mid 🇬🇧 English
ICH GCP eTMF CTMS ICF review Protocol amendments

Descripcion del puesto

About the role

ICON Strategic Solutions is hiring a Site Activation Manager in a hybrid setting in Mexico City. This is a sponsor-dedicated role delivered through a partnership with ICON, covering United States study start-up and amendment activities. The position builds relationships with investigative sites, collects and reviews documents, supports ICF development and IRB approval, and works cross-functionally to activate sites and implement amendments on time.

Key responsibilities

  • Coordinate site start-up and activation delivery, resolve issues and build team capability.
  • Build strong working relationships with investigative sites and support a positive sponsor-site experience.
  • Collect, review, QC and file documents needed for submission and activation.
  • Review and negotiate ICF changes with sites and stakeholders, manage translations, checklists, filing and amendment updates.
  • Ensure IRB submissions are made and approval documentation is complete and activation-ready.
  • Support regulatory and clinical trial start-up across the US, including submission, approval and activation workflows.
  • Help sites and stakeholders meet Regulatory Greenlight (RGL) goals for timely activation.
  • Escalate risks, manage timelines and keep accurate records in systems such as CTMS and the eTMF.
  • Manage protocol amendments, related submissions, approvals, site communications and implementation.

Required profile

  • Solid site start-up and activation experience, able to manage competing priorities and develop a team.
  • Clinical trial start-up experience in a site-facing or dedicated site role.
  • Strong cross-functional collaboration and stakeholder management in a sponsor-partner model with ICON.
  • Excellent written and spoken English, with strong organization and judgment.
  • Ability to work independently across North American time zones.
  • Legal right to work in the country where the role is based.

Required skills

  • Solid understanding of ICH GCP, ethics committee (IRB) requirements and US regulatory submission processes.
  • Experience with document collection, QC and filing, and with ICF review, negotiation and amendment management.
  • Experience with clinical trial management, electronic trial master file or comparable research systems.

What we offer

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
  • Retirement and pension plans, life assurance and disability coverage.
  • Employee assistance programmes and learning and development opportunities.

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Source : ats:workday

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