Clinical Start-up

hace 14 horas

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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