Sr Start-up

hace 1 semana

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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