.As a Quality Clinical Trial Manager, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
You will be a dedicated resource to one of our clients, embedded in their working environment, systems, and processes.
You will be engaged in a wide range of interesting and challenging tasks including developing a plan with the Study Clinical Trial Manager to ensure the team is properly supported in Inspection Readiness Activities and providing ongoing support during the pre, during, and post-inspection readiness phases.What you will be doing: Develop an Inspection Readiness Support Plan with the Study CTM, Asset Lead, QA Rep, and Dev Ops Quality Sr. Director or designee.Identify areas that may need additional resource support.Lead storyboard, CAPA, and deviation creation and reviews with the Study Teams.Plan and lead Study team IR support meetings based on QA's plan of action and Study Team's needs.Coordinate with Study team leadership and QA to identify key quality issues and plan of action.Support QA in IR team meetings.Assist with Stakeholder engagement across Study programs to ensure compliance with IR prep activities.Maintain training on up-to-date regulations and IR best practices.Support of DOQ and supporting departments teams during lulls in inspection.Ensure adherence to GCP and all applicable local and internal regulations.Develop and maintain key information for Inspections, Lessons Learned, trainings, and new processes on the Dev Ops Quality Sharepoint site.You Are: BS/BA degree or a relevant degree with a strong emphasis on science; Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.Extensive experience in Inspection Preparation/Inspection participation.Ability to effectively manage multiple priorities simultaneously.Experience in all phases of a clinical trial lifecycle from initiation to clinical study report.Why ICON: Our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs.
In addition, our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.
Our success depends on the knowledge, capabilities, and quality of our people.
That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development