Associate Director, Clinical Operations

Your experience includes… • 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. • 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 • In depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives. • Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel • FDA and other regulatory inspection experience is a plus • Current rare disease experience and/or gene therapy experience is highly preferred • Effective project management skills, cross-functional team leadership and organizational skills • 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 You are interested in… • Actively engage in day-to-day clinical trial management activities and lead the cross-functional study team • Contribute to the development and presentation of clinical trial operational strategy and updates to leadership • Provide input into baseline budget development and management, timeline development and management • 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 • Review, contribute to and/or author study Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports and Regulatory submission documents • Conduct on-going trial risk identification and analysis, and develop risk-based mitigation strategies in order to maintain study deliverables • Oversee, manage and ensure clinical trial(s) are executed in compliance with key metrics, timelines, budget, operational and quality standards (ICH/GCP/SOPs) • Oversee and ensure the CROs and Third Party Vendors are performing in alignment with study plans and are delivering per the scope of work • Lead the feasibility assessment to select relevant regions and countries for the study. • Oversee and/or conduct site evaluation and selection, and liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships • Lead the development of and oversee implementation of patient recruitment and retention strategies and act on any deviations from plan • Oversee and provide input to the development of study specific documents, including site training materials, case report forms (CRF), statistical analysis plan, and other study plans and manuals • Lead and/or participate in regular review of clinical trial data and metrics, including protocol deviations, to ensure timely identification and closure of data quality issues and non-compliance by sites • Develop, monitor and manage budget for clinical trial(s) including proposals, contracts, and scope changes for study vendors • Provide input to the study drug and clinical supplies forecasting and oversee drug accountability and drug reconciliation • Escalate issues related to study conduct, quality, timelines or budget to line management and other stakeholders and develop and implement appropriate actions to address issues • Ensure inspection readiness through the study lifecycle and support internal audits and external inspection activities and contribute to CAPAs as required • Oversee set-up and maintenance of study systems and documents by CRO, including Trial Master File (TMF)