Sr Start-up

hace 3 semanas


Ciudad de México Fortrea A tiempo completo

**Be the Catalyst for Clinical Trial Activation**Drive the momentum of vital clinical trials as the primary contact for investigative sites in a global perspective (focused on North America projects). Your expertise in local/regional regulations will ensure swift and compliant start-up, working with diverse stakeholders to bring innovative treatments closer to patients.**Your Impact**:- Own the collection and quality review of essential study documents.- Navigate IRB/EC/Regulatory Authority submissions with confidence.- Proactively anticipate and resolve start-up hurdles, ensuring timelines are met.- Mentor and guide team members, sharing your regulatory mastery.- Liaise with clients and internal teams, providing expert insights.- Contribute to best practices and process optimization within the region.**Your Expertise**:- 5+ years in clinical research start-up projects and keen expertise on regulatory affairs with deep ICH-GCP and local regulation knowledge.- Proven ability to manage site start-up activities and documentation.- Strong communication, negotiation, and problem-solving skills.- Experience collaborating with investigative sites and project teams.- Fluency in English and the local language.Learn more about our EEO & Accommodations request here.



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