ICON Strategic Solutions seeks an experienced Clinical Trial Manager to oversee end-to-end clinical trial operations in a sponsor-dedicated model. The role encompasses study start-up, regulatory submissions, site contracting, budget management, and vendor oversight to support global clinical research initiatives.
Responsibilities
Lead country-level study start-up, site activation, and regulatory authority submissions
Manage Clinical Trial Agreement negotiations and investigator/site budget preparation
Provide operational oversight of assigned trials from initiation through close-out
Coordinate vendor management and import/export compliance for trial materials
Serve as primary stakeholder contact for investigators, sites, and internal teams
Requirements
8+ years of clinical research or clinical operations experience
Proven expertise in clinical trial management and study start-up activities
Strong background in regulatory submissions, approvals, and IEC/IRB query management
Experience negotiating Clinical Trial Agreements and site budgets
Knowledge of import/export licensing for investigational products
Familiarity with ICH-GCP guidelines and local regulatory compliance
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