Med Monitoring Associate II

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Assist the Medical Affairs physicians (Medical Affairs Lead and Medical Monitor) with the following:

• Medical/safety review of draft / final clinical study documents including: protocol synopses, protocols, protocol amendments, letters of clarification, Informed Consent Forms, Case Report Forms, Data Validation Specifications, Statistical Analysis Plans including Table, Figure and Listing (TFL) shells, safety data, adverse event/concomitant and prior medication and procedures/medical history coding, TFLs, narratives, Clinical Study Reports. applicable background information such as Investigator Brochures, analysis population assignments, and other applicable documents as needed
• Analysis and interpretation of study safety and pharmacodynamic data
• Protocol deviation impact planning and impact assessments
• Preparation and/or review of Medical Affairs-related sections of risk assessment documents, Medical Monitoring Plans, and other documents as applicable
• Conduct literature searches and summarize/extract the information needed to support other Medical Affairs tasks
• Independently interact with clients and sites to obtain necessary and relevant information, and deal with queries through effective decision making
• Triage and participate in communications between the Sponsor, sites, and ICON project staff regarding study design and risk mitigation; protocol, subject eligibility, data, or other study-related questions; and documenting, tracking, and follow-up on issues
• Contribute to the development of kick-off meeting slides to specific client and study needs and help with presenting Medical Affairs sections of the kick-off meeting slides and protocol introduction;
• Attend safety meetings; share and file important information regarding the study

Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON 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 through the form below.