Clinical Operations Manager

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) Manage and oversee study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Ensure compliance with the clinical trial registry requirements About you: You are an individual with excelle…