Job Description
When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Global Site Start-up (SSU) Lead is accountable for the global execution of site activation for assigned clinical trials, performing responsibilities with moderate oversight. The Global SSU Lead is accountable for ensuring site start-up is efficient, timely and in accordance with the sponsor Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes to ongoing process improvement initiatives. CORE JOB RESPONSIBILITIES: Site Start-up Strategy Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions. Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making. Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives. Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness. Country Start-up Partner with cross functional and CRO
