PRA Health Sciences
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.Working fully embedded within one of our clients in medical devices, with the support of ICON right behind you, you’ll be at the heart of our client’s innovation. As Clinical Research Associate, you will be dedicated to one of our global clients; a well-established company active in Medical Devices.As a Clinical Research Associate, you will have the opportunity to experience the full lifecycle of a project.The key areas of your work:Provide leadership in execution of clinical studies to deliver high quality data to supportClient on time, within budget and in compliance to all applicable regulations and client proceduresDrive adoption of compliant clinical study execution practices through out client active in clinical studies including research and testing of products involving human beingsDevelop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.Support, update and maintain the Clinical Trial Management System application for clinicalstudy execution and reportingKey Performance Indicators are:Target versus actual duration for the following:Protocol Development (PD)Data Capture Development Tool (DCDT)Site Activation (SA)Study Duration (SD)Database Lock (DL)Clinical Study Report (CSR)Studies monitored according to monitoring planStudies completed on time, on budget, and without CAPA or major protocol deviations.Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:Bachelor or Masters in Science or Healthcare discipline.Approximately 5 years related experience in clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry).At least 3 years of experience as a Clinical Research Associate monitoring clinical studies.Experience in using EDC and CTMS systems is desirable.Experience with direct line management of staff including hiring, training, oversight and mentoring.Good command of written and spoken English language.Excellent verbal and written communications skills Dutch, English and possible French.A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations.Ability to work very accurate and thorough.Excellent record-keeping skills; good documentation practice.Flexibility in work hours and readiness to travel, (app 3 visits per month)What’s in it for you?A Home based position, once a month you can meet your colleagues at the office in Eindhoven, if you like more times thats is of course possible.A very good Life-Work balanceVisits but no more than 2 or 3 times per month to sitesA fantastic innovative work environment in diagnosticsBenefits of Working in ICON: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.At 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.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, color, 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.
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