Job title: Clinical Study Startup Specialist

• Grade: L2
• Hiring Manager: Martin Sanchez
• Location: Ciudad de México

• Partner with Clinical Research Organizations (CROs), Clinical Operations teams, and Feasibility partners to improve overall study startup metrics and implement processes.
• Coordinates the start-up deliverables of assigned studies in all aspects of start-up (including overall accountability for delivery to time, cost, and quality etc. and communication with relevant stakeholders).
• Develop and implement global study startup project plans and manage the collection and analysis of all data to influence study startup timelines.
• Provide accurate projections and timelines based on country’s historical performance with the support of the CRO partner.
• Monitor start-up activities, identify risks, and manage issues independently, Ensure compliance with local regulatory guidelines and provide support to resolve local issues.
• Report progress and challenges in trials to the clinical team during team meetings.
• Oversee collection of investigator and regulatory documents for study submissions.
• Support negotiations with sites and maintain quality control of study start-up documents.