Study Start Up Associate II

at  Icon plc

Job Advert Posting
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 fulfill our mission to advance and improve patients’ lives.
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations.
With our patients at the center 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.

THE ROLE

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

• Provide country specific SSU expertise to Study Start Up team leads and project teams.
• Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies.
• Develop, finalize, and review Master and Country Specific Subject Information Sheets/Informed Consent Forms.
• To prepare EC and regulatory submission packages according to the relevant requirements for selected countries

TO BE SUCCESSFUL IN THE ROLE YOU WILL HAVE:

• A Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.
• A minimum of 2 years of experience or understanding of clinical study start up requirements and activities.
• Experience of Clinical Trial operations and meeting regulatory guidelines
• Proficient project management skills
• Fluency in the local language and English is essential.