As a SMA I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
ResponsibilitiesWhat you will be doing:
receiving all study documentation from the Project Team, Client, or Clinical Research Associatelogging information into an internal tracking systemscanning documentation to the correct location in an electronic repositorysetting up the Trial Master File (TMF) per the client-approved specifications and PRA standardsmaintaining files in regards to upkeep of the folders, application of study-specific labels, and assessment of supply needs for each aligned projectrunning monthly reports to ensure accuracy of the filesdelivery of the Trial Master File at study closeoutthe review and preparation of the Trial Master File for audits and TMF reviewsthe resolution of any internal quality control findings and audit findingsrunning of projections and maintenance of department reportscreation of checklists and daily quality control schedulesattending project calls with clinical team members applicable; and management of larger and/or more complex studiesQualifications
You are:
Undergraduate degree (e.g. Associate’s or Bachelor’s) in a clinical, science or related fieldPrior experience in records management, office support or similar dutiesPrior experience using computerized information systemsPrior industry experiencePrior experience in a leadership rolePrior accountability with vendors or clientsRead, write, and speak fluent English; fluent in host country languageKnowledge of ICH/GCP, local regulatory authority and clinical development regulations
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.
https://careers.iconplc.com/reasonable-accommodations
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.