Clinical Operations Manager

<p><strong>Your experience includes…</strong>&nbsp;</p> <ul> <li>Bachelor’s degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.</li> <li>Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out, including managing clinical CRO and other vendors, budgets and timelines</li> <li>In depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives.</li> <li>Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel</li> <li>FDA and other regulatory inspection experience is a plus</li> <li>Current rare disease experience and/or gene therapy experience is highly preferred</li> <li>Effective project management skills, cross-functional team leadership and organizational skills</li> <li>Ability to thrive in a fast-paced environment with a demonstrated ability to prioritize and manage multiple competing tasks, and flexibility to adapt to changing program needs</li> </ul> <p><strong>You are interested in…</strong>&nbsp;</p> <ul> <li>Actively engage in day-to-day clinical trial management activities and lead the cross-functional study team</li> <li>Contribute to the development and presentation of clinical trial operational strategy and updates to leadership</li> <li>Provide input into baseline budget development and management, timeline development and management</li> <li>Identify outsourcing needs of the study and lead the team in the evaluation, selection and management of global Contract Research Organizations (CROs) and other vendors</li> <li>Review, contribute to and/or author study Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports and Regulatory submission documents</li> <li>Conduct on-going trial risk identification and analysis, and develop risk-based mitigation strategies in order to maintain study deliverables</li> <li>Oversee, manage and ensure clinical trial(s) are executed in compliance with key metrics, timelines, budget, operational and quality standards (ICH/GCP/SOPs)</li> <li>Oversee and ensure the CROs and Third Party Vendors are performing in alignment with study plans and are delivering per the scope of work</li> <li>Lead the feasibility assessment to select relevant regions and countries for the study.</li> <li>Oversee and/or conduct site evaluation and selection, and liaise with clinical site staff and Investigators as appropriate to ensure optimal sponso