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Lead end-to-end operational delivery of clinical studies from site initiation through study close-out at Novartis (DTX Pharma). Serve as the primary country study contact and local lead for assigned clinical trials, managing all aspects of study execution in Mexico City.
Key responsibilities include developing study execution plans, timelines, and risk mitigation strategies; driving patient recruitment activities and implementing contingency plans to achieve enrollment targets; coordinating cross-functional teams across a global matrix environment to ensure timely, compliant, and high-quality study execution; monitoring study progress and identifying operational challenges; maintaining oversight of data quality and query resolution; ensuring compliance with Good Clinical Practice and regulatory requirements; reviewing monitoring visit outcomes and driving issue resolution; and managing study budgets, contracts, essential documentation, and site payment activities.
You will partner with cross-functional teams, investigators, and research sites to accelerate patient recruitment, ensure the highest standards of quality and compliance, and contribute directly to the advancement of potentially life-changing therapies. This role requires strong project management, problem-solving, and stakeholder management capabilities, with demonstrated ability to lead in a global environment.
Required: Bachelor's degree in a scientific or health-related discipline; minimum five years of clinical research project management and/or clinical trial monitoring experience; strong understanding of clinical drug development and study execution processes; comprehensive knowledge of international clinical research regulations and quality standards; effective negotiation and conflict resolution skills; excellent written and verbal communication skills in English.
Desired: Advanced degree in a scientific or health-related discipline; 7-10 years of clinical trial and project management experience in a global research environment.
