Study Start Up Associate II - Regulatory - Medical Device

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research 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.

As a Study Start Up Associate- Regulatory II "Medical Device" at ICON, you'll work 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 trials on pre-market or post-market Medical Devices.

The Role

Provide country specific Study Start Up 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 (SIS/ICFs)

Perform independent quality review of submission packages.

Responsible for the translation and coordination of translations for documents required for submissions.

Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system

Copy and route incoming correspondence, internal documentation, etc., as appropriate

Responsible for the timely follow-up for queries made by EC/CA

Responsible for the collection of critical documents required for MD Release

Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries

Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related.

Develop and maintain effective relationships with local, regional and country authorities

Perform regulatory document for maintenance e.g. amendments, periodic updates and safety letters

Comply with all department requirements regarding information provision and status updating and reporting

Responsible for TMF inspection readiness for SSU documents

May be support of Study start-up Associate Contract for contact with local site administrations

May assist in mentoring, supporting and assessment of new SSUA-R.

What you need

A bachelor's degree or related experience is preferred

2 to 3 years of SSU experience in Medical devices area.

Good organizational skills and the ability to manage multiple tasks

Local language and English language skills

Experience in a clinical research environment with specific experience in study submissions or in related field such as where submissions is a primary part of your role, but required in Medical Device area.

Requires minimum supervision for assigned responsibilities and tasks.

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 through the form below.