ICON is seeking a Clinical Study Manager in Mexico City to lead operational delivery of pharmaceutical trials for a dedicated sponsor client. The role involves coordinating project activities, managing strategic partners, ensuring regulatory compliance, and overseeing study execution to meet quality, timeline, and budget objectives.
Responsibilities
Support execution of assigned studies in compliance with ICH GCP, local regulations, and SOPs
Oversee strategic partners including CRO selection, budget negotiation, and performance supervision
Conduct and manage oversight activities including monitoring visits, document review, and protocol deviation analysis
Ensure trial operational readiness, prepare for regulatory inspections, and maintain compliant trial master files
Support data review, database lock preparation, and clinical study report writing processes




Requirements
5+ years pharmaceutical industry or clinical research organization experience
3+ years clinical study management oversight with trial assistant or CRA background
Experience with early-phase or Phase II/III integral clinical studies
Proven project management success within scope, time, and budget constraints
Knowledge of US CFR, EU CTD, ICH GCP, and global regulatory compliance
Strong leadership, organizational, and stakeholder management capabilities
Fluent business English (oral and written); PMP or PRINCE2 certification advantageous
Compensation:
Competitive base salary and performance-related incentives

📌 Clinical Study Manager (Xico)
🏢 Icon
📍 Xico