SMA I

As a SMA I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• receiving all study documentation from the Project Team, client, or Clinical research associate
• logging information into an internal tracking system
• scanning documentation to the correct location in an electronic repository
• setting up the Trial Master File (TMF) per the client-approved specifications and PRA standards
• maintaining files in regards to upkeep of the folders, application of study-specific labels, and assessment of supply needs for each aligned project
• running monthly reports to ensure accuracy of the files
• delivery of the Trial Master File at study closeout
• the review and preparation of the Trial Master File for audits and TMF reviews
• the resolution of any internal quality control findings and audit findings
• running of projections and maintenance of department reports
• creation of checklists and daily quality control schedules
• attending project calls with clinical team members applicable; and management of larger and/or more complex studies

You are:

• Undergraduate degree (e.g. Associate’s or Bachelor’s) in a clinical, science or related field
• Prior experience in records management, office support or similar duties
• Prior experience using computerized information systems
• Prior industry experience
• Prior experience in a leadership role
• Prior accountability with vendors or clients
• Read, write, and speak fluent English; fluent in host country language
• Knowledge of ICH/GCP, local regulatory authority and clinical development regulations

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.