Clinical Quality Compliance Lead job in Madrid | ICON __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions__vacancyopjusttionswidget.opt-Remote Working __ RemoteAs 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:5 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 authorityTeam 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.Share:Location: MadridReference: 2024-110242 Categories Quality Assurance__vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions__vacancyopjusttionswidget.opt-Remote Working __ RemoteOur people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader . See all locations Read moreA better career. A better world. A better you. Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader . See all locations Read moreA better career. A better world. A better you. Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader . See all locations Read moreA better career. A better world. A better you. Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader . See all locations Read moreA better career. A better world. A better you. Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader . See all locations Read moreAround268,000 people areemployed by the UK life sciences industry and as one of thefastest-growing sectors, this number is expected to continue rising. Lifesciences is a flourishing job market,Teaser labelAround268,000 peopleare employed by the UK life sciences industry and as one of thefastest-growing sectors, this number is expected to continue rising.ICON has been providing outsourced development services on a global scale to the pharmaceutical, biotechnological and medical device industries for 25 years. Employing over 10,000 employees across 38Teaser labelICON has been providing outsourced development services on a global scale to the pharmaceutical, biotechnological and medical device industries for 25 years.ICON began its journey to international success from humble beginnings in Ireland in 1990.Started by Dr John Climax and Dr Ronan Lambe, the first office had five team members and since then has grownTeaser labelICON began its journey to international success from humble beginnings in Ireland in 1990.At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own IRegulatory, Drug Safety/ Quality Assurance & Other rolesLocationMadridRemote WorkingRemoteBusiness AreaICON Strategic SolutionsJob CategoriesQuality AssuranceJob TypePermanentDescriptionAs a Clinical Quality Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Under the guidance of the Regional DirectoAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own ITitle: Senior Auditor (Technology & CSV)At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advanceRole : Auditor, Quality Assurance This role will be based in one of the countries listed GCP experience is mandatory for this role At ICON, it's our people that set us apart.As a global provider of drICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech#J-18808-Ljbffr
