Part-Time Cta - . Fte

As a part time CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. 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. Seeking a part time CTA for one of our global sponsors - Working 0.5FTE Your responsibiities include;

• Liaise with clinical team to help compile initial and amended regulatory / administrative document package for the central and local IRB/IECs and sites (including site Administrations).
• Track the status of regulatory readiness and alert the Clinical Study Manager appropriately to any issues/challenges in getting sites ready.
• If relevant, work with translating agencies to support translation of relevant clinical study documents.
• Check that appropriate versions of legal documents (e.g. Confidentiality Agreements, CTA) are used and database is kept current. Liaise with legal to track and process agreements.
• Responsible for efficient upload of trial related documents/communications in to CREDI.
• In collaboration with CSMs and CRAs, responsible to set-up and keep country and site Trial Master Files (“TMFs”) continuously up to date according to regulatory and Sponsor requirements.
• Assists local trial team with the creation, ordering, and mailing of any study tools including recruitment materials as well as newsletters, blast email communications, blast faxes, etc.
• Supports local trial team with ordering/tracking/mailing of any necessary trials supplies including the regulatory binder, lab kits.
• Support the CSM with the coordination of internal and external suppliers, including customs, to confirm import of all clinical trial supplies (including drug supply).
• Coordinate shipment of clinical trial supplies to local sites.
• Co-ordinate relabeling of Investigational Medicinal Product (“IMP”) at warehouse when needed.
• Supports the Trial Commitment Form (“TCF”) specialist. Provide support for trial budget and accounting.
• Support budget planning and forecast. Support tracking and processing of Grant applications.
• Track, process and release milestone payments to sites in collaboration with local study team and finance.
• Track, process and release payments to vendors in collaboration with local study team and finance

Experience required;

• Various educational background.
• Preferably, three years’ work experience with at least one year experience in clinical research.
• Basic knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Excellent communication, presentation, interpersonal skills both written and spoken, with an ability to inform, influence, convince, and persuade.
• Candidates must be based in Denmark, with Danish language skills

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.