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. What will you be doing? Expert Level - Medical Device • Works on multiple trials in different disease areas • Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team • Acts as Lead SM-training other SMs on study • Develops site start up documents for studies including SIV agenda • Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines) • Represents LTMs or SMs on SMTs/meetings • Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial • Supports country budget development and/or contract negotiation in liaison with CCS colleagues • Assists with ASV Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces – Primary/Other: • Primary interfaces: Provider Functional Manager, Sponsor Point of Contact, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. • Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.). What do you need to have? + • BA/BS degree/Degree in a health or science related field or equivalent industry experience • Specific therapeutic area experience depending on the services need. • Working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. • Demonstrate proficiency in IT skills for appropriate software and company systems. • Willingness to travel with overnight stay away from home according to business needs. • Proficient in speaking and writing in English and the country language where services will be provided. Effective communication skills, oral and written. • Experience with monitoring and site management of complex Early Phase of clinical development, as applicable. • Minimum of 6 years clinical trial monitoring experience • Strong leadership skills + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Benefits 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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