Clinical Start-Up & Trial Lead

<p><b><span>Position Summary</span></b></p><p><span>The Clinical Start-Up &amp; Trial Lead (Start-Up &#43; 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.</span></p><div></div><p><b><span>Key Responsibilities</span></b></p><p><b><span>Start-Up Responsibilities</span></b></p><ul><li><span>Lead country/site feasibility, site selection, and activation strategy in collaboration with project teams.</span></li><li><span>Oversee development and negotiation of site contracts, budgets, and regulatory/ethics submissions.</span></li><li><span>Track and report on start-up timelines, metrics, and bottlenecks; drive resolution.</span></li><li><span>Collaborate with Regulatory, Legal, and Contracts to ensure timely delivery of activation packages.</span></li><li><span>Ensure readiness for site initiation visits (SIVs) and coordinate site training.</span></li></ul><p></p><p><b><span>Clinical Trial Lead Responsibilities</span></b></p><ul><li><span>Provide end-to-end operational oversight for the assigned study(ies), including CRO/vendor and site performance.</span></li><li><span>Lead cross-functional study team meetings and act as key escalation point for site-level issues.</span></li><li><span>Monitor overall study progress, timelines, and quality metrics; implement mitigation plans as needed.</span></li><li><span>Drive proactive risk identification and resolution, aligning with RBQM principles.</span></li><li><span>Ensure inspection-readiness through quality oversight of TMF, monitoring reports, and issue management.</span></li><li><span>Partner with data management, medical, and safety teams to ensure clean, timely data delivery.</span></li></ul><div></div><p><b><span>Qualifications</span></b></p><p><b><span>Education &amp; Experience</span></b></p><ul><li><span>Bachelor’s degree in life sciences or a related field; advanced degree preferred.</span></li><li><span>6&#43; years of clinical research experience, including significant site start-up and CTL/project management responsibilities.</span></li><li><span>Prior experience in a CRO, biotech, or pharma environment required.</span></li><li><span>Strong knowledge of ICH GCP, regulatory requirements, and clinical trial lifecycle.</span></li></ul><p></p><p><b><span>Skills &amp; Competencies</span></b></p><ul><li><span>Proven ability to manage multiple timelines and priorities with attention to detail.</span></li><li><span>Strong project leadership and stakeholder engagement skills.</span></li><li><span>Familiarity with EDC, CTMS, eTMF, and site start-up platforms (e.g., Veeva Vault, Medidata).</span></li><li><span>Excellent communication, negotiation, and team-building skills.</span></li><li><span>Solution-oriented mindset and comfort with ambiguity in fast-paced environments.</span></li></ul><div></div><p><b><span>Travel Requirements</span></b></p><ul><li><span>Up to 20% domestic and/or international travel, as needed.</span></li></ul><div></div><p><b><span>Why Join Us?</span></b></p><p><span>We offer a dynamic environment where innovation, accountability, and integrity are valued. In this dual-role position, you&#39;ll have an opportunity to shape trial success from the very beginning and carry that leadership throughout the study lifecycle.</span></p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>