Clinical Trial Manager in Delhi, भारत

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
• Legal right to work in India