Clinical Start-Up

hace 1 día

Ciudad de México, Ciudad de México Fortrea A tiempo completo

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.

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