Site Activation Manager
icon · Mexico City
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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Publicado hace 12 horas
Expira en 1 mes
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Mexico City