Strategic Clinical Start-Up & Trial Lead

Fortrea; Mexico; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

Fortrea is seeking a Clinical Start-Up & Trial Lead in a hybrid position based in Mexico City. You will drive start-up strategy, coordinate site activation, and oversee end-to-end trial execution from site initiation through close-out.

You will collaborate with Regulatory, Legal, and CRO/vendor teams to ensure timely delivery of activation packages and maintain study quality metrics across phases.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Advanced degree preferred.
• 6+ years of clinical research experience including site start-up and CTL/project management.
• Experience in CRO/biotech/pharma environments.

Responsibilities

• Lead country/site feasibility, site activation strategies with project teams.
• Oversee contracts, budgets, regulatory submissions, and ethics submissions.
• Track start-up timelines, metrics, and bottlenecks; drive issue resolution.
• Coordinate with Regulatory, Legal, and Contracts for activation packages.
• Ensure readiness for SIVs and coordinate site training.
• Provide end-to-end operational oversight for assigned studies.
• Lead cross-functional study team meetings and escalate site issues.
• Monitor study progress, timelines, and quality metrics; implement mitigations.
• Identify risks proactively and align with RBQM principles.
• Ensure inspection-readiness through TMF and monitoring reports.

Skills

Timeline management

Project leadership

Regulatory coordination

Communication skill

Ambiguity handling

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

EDC

CTMS

eTMF

Veeva Vault / Medidata

Job description

Fortrea is seeking a Clinical Start-Up & Trial Lead in a hybrid position based in Mexico City. You will drive start-up strategy, coordinate site activation, and oversee end-to-end trial execution from site initiation through close-out.

You will collaborate with Regulatory, Legal, and CRO/vendor teams to ensure timely delivery of activation packages and maintain study quality metrics across phases.