As a Clinical Quality Compliance Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be responsible for streamlining the strategic integration of the quality and training function as key factors for the successful execution of clinical trials.What you will be doing:Support Clinical Quality & Training Manager and TA Heads by main taining appropriate and consistent training records across CDC.Identify and share the 'Clinical protocol quality' focus areas and targets to country level:Give quality input to the strategic plan based on upcoming clinical trial activities and Quality Management Review(QMR)Identify potential critical areas of the quality non-compliance and introduce preventative actionsPrepare and execute the clinical protocol quality plan based on QMR results and issues identified in previous year(s)Extract quality metrics and share them with appropriate stakeholdersTrain appropriate parties in regulations and requirements to achieve audit/ inspection readinessManage the risk, escalate issues and provide guidance to the clinical team:Perform quality visits and checks to verify the clinical protocol quality status and provide feedbackIdentify issues based on data and trend analysis, inform the appropriate stakeholders about them, impose the solutions, check the implementation of the solution, escalate the issues to higher level management, if necessaryIdentify improvement areas and deliver quality protocol training to achieve the high level of quality in trial conductExplain issues, answer quality questions (GCP) and provide training to all stakeholdersReview/develop CAPA during audits/inspectionsCreate an environment to achieve the clinical quality objectives:Adopt innovative approaches in planning and conduct state-of-art trainings to all stakeholders involved in the clinical trial conduct processCoach internal and external (PI, other relevant site staff) stakeholders by providing focus trainingsAct as a GCP and SOP expert and provide clarifications to all questions raisedProvide targets on clinical quality compliance metricsVerify compliance with targetsYou are:Relevant Sciences Degree5 years of experience as a CRA with increased responsibility.Minimum 2 years of experience as a clinical research / project manager working in the pharmaceutical industry.In-depth understanding of clinical quality with experience in implementing clinical quality management plans across sites.Strategic mind-setAnalytical skillsPlanning and execution skillsAbility to lead without authorityExcellent negotiation, communication & presentation skillsTeam oriented personality with high degree of flexibility - to ensure successful trial deliverablesAbility to share knowledge and train other and proven successesAbility and willingness to adjust quickly to new situations in a continuously developing environmentProven decision making and problem-solving capabilitiesAbility to go beyond current responsibilitiesAbility to manage multiple prioritiesHigh focus on delivery and qualityAbility to build and maintain strong working relationships with internal and external stakeholdersWhy 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.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.#J-18808-Ljbffr
