Senior Clinical Trial Manager
BE
PRA Health Sciences
Req #: 111688
Type: Belgium
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Overview: 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. For our client in the Antwerp region, we are looking for an experienced Local Trial Manager (Snr Clinical Trial Manager) to join our ICON team! You will be working for one of the most attractive employers in Belgium, creating a real impact on the health of patients worldwide. Responsibilities: As a Local Trial Manager (LTM) you are responsible for the trial management of the clinical trials at country level. These responsibilities include: * Operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. * To ensure the local trial team is delivering quality data and trial documents/records * Partnering with the Study team to ensure overall study delivery at country level As you have a senior level you will be able to independently execute the local trial management services, have knowledge on this level already and process leadership in your role. What you will be doing: * Site Selection through participation in site feasibility (site qualification visits, site qualification visit report and country feasibility report. * Ensure the local team is meeting recruitment targets (if needed develop specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting) * Act as primary company contact for assigned trials at country level: Attend Investigator Meetings as needed * Drive study compliance (initiate corrective and preventive actions (CAPA) when the trial deviates from plans) * Communicate study progress and issues to study management teams and Quality & Compliance team * Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas * Vendor management at the country level and support vendor selection * Manage the local study supply * Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training * Contribute to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates * Report all safety issues * Ensuring inspection readiness at all times and follow-up of actions after audits * Ensure accurate finance reporting and trial delivered within budget * Adhere to the local regulatory requirements * Timely and accurate reporting Qualifications: You hold * a Degree in a health or science related field (bachelor or master level) * 3 to 5+ years of trial management experience. * Strong working knowledge of ICH-GCP, company standard operating procedures, local laregulations, assigned protocols and associated protocol specific procedures. * Strong IT skills in appropriate software and company systems. * Proficient in speaking and writing in Dutch, French and English. Good written and oral communication skills as appropriate. 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. 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. #LI-VV1 #LI-Hybrid
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