Clinical Start-Up & Trial Lead (Start-Up + CTL)

Fortrea; Mexico; On-site; 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

Position Summary

The Clinical Start-Up & Trial Lead (Start-Up + CTL) is responsible for the strategic planning, coordination, and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out, serving as the primary operational point of contact for internal teams, vendors, and clinical sites.

Key Responsibilities

Start-Up Responsibilities

• Lead country/site feasibility, site selection, and activation strategy in collaboration with project teams.
• Oversee development and negotiation of site contracts, budgets, and regulatory/ethics submissions.
• Track and report on start-up timelines, metrics, and bottlenecks; drive resolution.
• Collaborate with Regulatory, Legal, and Contracts to ensure timely delivery of activation packages.
• Ensure readiness for site initiation visits (SIVs) and coordinate site training.

Clinical Trial Lead Responsibilities

• Provide end-to-end operational oversight for the assigned study(ies), including CRO/vendor and site performance.
• Lead cross-functional study team meetings and act as key escalation point for site-level issues.
• Monitor overall study progress, timelines, and quality metrics; implement mitigation plans as needed.
• Drive proactive risk identification and resolution, aligning with RBQM principles.
• Ensure inspection-readiness through quality oversight of TMF, monitoring reports, and issue management.
• Partner with data management, medical, and safety teams to ensure clean, timely data delivery.

Qualifications

Education & Experience

• Bachelor’s degree in life sciences or a related field; advanced degree preferred.
• 6+ years of clinical research experience, including significant site start-up and CTL/project management responsibilities.
• Prior experience in a CRO, biotech, or pharma environment required.
• Strong knowledge of ICH GCP, regulatory requirements, and clinical trial lifecycle.

Skills & Competencies

• Proven ability to manage multiple timelines and priorities with attention to detail.
• Strong project leadership and stakeholder engagement skills.
• Familiarity with EDC, CTMS, eTMF, and site start-up platforms (e.g., Veeva Vault, Medidata).
• Excellent communication, negotiation, and team-building skills.
• Solution-oriented mindset and comfort with ambiguity in fast-paced environments.

Travel Requirements

• Up to 20% domestic and/or international travel, as needed.

Why Join Us?

We offer a dynamic environment where innovation, accountability, and integrity are valued. In this dual-role position, you’ll have an opportunity to shape trial success from the very beginning and carry that leadership throughout the study lifecycle.

Learn more about our EEO & Accommodations request here.