CTA

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.

To be an integral part of the study team by providing administrative and project tracking support to the Project Manager(s) and Clinical Trial Manager(s) with emphasis on supporting inspection readiness

Recognize, exemplify and adhere to ICON's values which center on excellence in execution, exceeding expectations, and enhancing relationshipsAs a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needsTravel (approximately 10%) domestic and/or internationalTo possess a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs / Client systems (when applicable)To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archivalTo assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the studyTo share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all timesTo facilitate and coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriateTo assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)To run, review and analyse study reports for accuracy and work with the project teams to ensure updates are completed correctlyTo assist in coordination of study related payments, if applicableTo contact and serve as a contact for clinical sites for basic requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.)To assist in the tracking and distribution of safety reportsTo coordinate document translation, if requiredTo assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendasTo assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentationsTo assist with the coordination of various tracking reports, including but not limited to, team member tracking and trainingTo work in collaboration with internal and external colleagues to meet project objectives and timelines To Keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attentionTo maintain client and patient confidentialityOther duties as assigned

Minimum of 4 years’ experience in Global Clinical Trials.May perform all or some of the following responsibilities:1) May ensure the successful negotiation and ongoing management of clinical trial agreements with investigative sites and vendor agreements and associated budget management.2) Maintain accurate records, metrics and reports; identify gaps and report to management; make recommendations for process improvement and efficiencies3) May have some accountability for processes or groups of trials; operates with limited oversight4) Achieves successful delivery of site start-up, in-house site management and closeout activities meeting internal and external client requirements.5) Responsible for end to end process within countryBenefits 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.