Title: Associate Director Clinical Operations, Compliance – Process & Training role Location: Remote Duration: 6 months+ Key Responsibilities: Drive the development, optimization, alignment and implementation of clinical trial processes across Client Clinical DevelopmentPartner with equivalent Client functions for development, optimization and alignment of shared clinical trial processesIdentify and Lead Process Improvement opportunities at ClientEstablish and maintain the training curricula for Clinical Operations and support other Clinical Development functions, as neededDevelop Onboarding plans for Clinical OperationsSupport transition planning within Clinical Operations as neededProactively monitor compliance with Clinical Operations procedural documents and training requirementsDevelop and report process and training compliance metricsSupport and participate in internal audits and regulatory authority inspections, as neededSupport audit/inspection response development and CAPA implementation, as neededMaintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessaryLead and support efforts to increase compliance awareness and a culture of complianceKnowledge & Skills: In depth knowledge of international GCP regulatory requirementsDeep understanding of end-to-end clinical trial processesOrganizational AwarenessIndependently lead and manage cross-functional initiativesExcellent communication skills, provide clear and concise instructionsNegotiate sensitive issues in an objective mannerCritical and creative thinking to be able to resolve complex problemsAbility to prioritize and adjust workload to meet evolving department and regulatory needsLead by example to champion quality and compliance
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