Remote Associate Director Clinical Trials Operations

Sr. Manager / Associate Director Clinical Development Operations Remote but preference is East CoastReport to:Sr. Vice President, Clinical Development Operations (CDO)About Company Company (“RTX”) is a clinical-phase company. Our core technology combines proprietary dry-powder inhaler device technologies and advanced particle engineering-based inhaled drug formulation approaches to develop novel therapeutics that deliver the drug more directly to the lung and lung periphery, instead of in the oropharyngeal cavity. Position Description Manage end-to-end clinical contracts between external service providers (ESP) and internally at “RTX” Responsible for invoice review and adjudication with ESPLead role in annual budget projections for current and new ESPIdentify new ESPs as necessary Working with clinical development team colleagues, create and maintain internal clinical trial timelines and study-specific work plans using internal templates Prospectively identify gaps and constraints and prosecute findings with clinical development team Responsible for set up with ESP and logistics on all clinical trial shipments to and from research sitesSubject matter expert (SME) on device malfunction tracking, reporting, and remediation re-education at site and ESP levels Provide and deliver remediation training within context of internal standards and review Work with clinical development and clinical operations teams to create SME training as needed for clinical study conduct SME for “RTX” electronic training portal Sole management of GCP training matrix for Clinical Department Work with QA to identify training gaps and procure method for gap trainingResponsible for organizing and providing annual company wide GCP training in collaboration with Heads of QA and CDO Sole “RTX” manager and curator of biological samples from clinical trials with approved external reference labs Responsible for liaising with external parties ensuring on-time analysis and data transfers Core NDA preparation team member Key planning roleProvide information for sectionsCoordinate timing and quality of deliverables from ESPs Candidate Profile Internally motivated to deliver high-quality work products on time and within budgetExcellent communication and planning skillsAbility to recognize personal information gaps and seek advice and counsel of internal associates and engage in appropriate self-studyThrives on learning new aspects of clinical development work and integrating these with current expertiseAble to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needsWorking knowledge of ICH GCPMinimum of 7 years working in clinical development and/or clinical operations roles at a biopharma or clinical contract research organization with a minimum of 4 years in a management capacityAdvanced working knowledge of Microsoft Excel, PowerPoint, and ProjectBonus: working experience using Smart Sheets®, One-Pager Pro™, Medrio and Oracle clinical databases