Site Activation Lead - Clinical Trials (Hybrid, MX)

ICON Strategic Solutions; Ciudad de México; Hybrid; MXN 520,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement planning options

Global Employee Assistance Programme

Job summary

ICON Strategic Solutions in Mexico City is seeking a Site Activation Manager to coordinate start-up and activation activities for North American studies. You will build strong sponsor-site relationships, manage essential document collection, and ensure timely regulatory submissions and activation across the US and Canada.

The role requires experience in ICH GCP, IRB/REB processes, and ICF review, with a focus on cross-functional collaboration within ICON’s sponsor-partner framework.

Qualifications

• Clinical trial start-up experience in a site-facing or dedicated site role.
• Solid understanding of ICH GCP, applicable ethics committee requirements (IRB/REB), and regulatory submission processes across the United States and Canada.
• Fluency in English.
• Experience with essential document collection, QC, and filing.
• Experience with ICF review, negotiation, and amendment management.
• Strong cross-functional collaboration and stakeholder management skills within a sponsor-partner operating model involving ICON.

Responsibilities

• Coordinate site start-up and activation delivery, resolving issues and developing team capability.
• Build strong relationships with investigative sites and support a positive sponsor-site experience throughout start-up.
• Collect, review, QC, and file essential documents required for submission and activation.
• Review and negotiate ICF changes with sites and stakeholders; manage translations, checklists, filing, and amendment updates as required.
• Ensure REB submissions are made and approval documentation is complete and activation-ready.
• Support regulatory and clinical trial start-up activities across the US and Canada, including coordination of submission, approval, and study activation workflows.
• Collaborate with sites and internal stakeholders to set and achieve Regulatory Greenlight (RGL) goals that support timely site activation.
• Escalate risks, manage timelines, and maintain accurate documentation and tracking in systems such as CTMS and the eTMF.

Skills

Fluency in English

Job description

ICON Strategic Solutions in Mexico City is seeking a Site Activation Manager to coordinate start-up and activation activities for North American studies. You will build strong sponsor-site relationships, manage essential document collection, and ensure timely regulatory submissions and activation across the US and Canada.

The role requires experience in ICH GCP, IRB/REB processes, and ICF review, with a focus on cross-functional collaboration within ICON’s sponsor-partner framework.