Clinical Trial Manager

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.

We are looking for a Local Study Manager based in Belgium

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies • Leads and optimize the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations. • Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. • Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head. • Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.

Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*). • Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies). • Good knowledge of international guidelines ICH[1]GCP as well as relevant local regulations. • Proven ability to lead and motivate cross[1]functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality. • Excellent project management skills. • Excellent team building and interpersonal skills. • Excellent organisational skills. • Excellent verbal and written communication skills. • Excellent ability to prioritize and handle multiple tasks. • Excellent attention to details. • Excellent knowledge of spoken and written Dutch, English and French. • Good negotiation skills. • Good ability to learn and to adapt to work with IT systems. • Ability to travel nationally and internationally as required.

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