Study Start Up Associate II - Med Device
About the role
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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre 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 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:
To review and negotiate clinical site investigator contracts and budgets.
Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
Prepare and coordinate preparation of contractual documents and correspondence
Facilitate the indemnification process between the study sponsor and the site.
Perform regulatory document for maintenance e.g. amendments, periodic updates and safety letters.
Prepare, review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trials or late phase studies authorizations and approvals.
Collect critical documents for MD release
What you need:
A bachelor's degree or related experience is preferred
2 year of SSU experience in Medical devices area.
Local language and English language skills
Experience in a clinical research environment with specific experience in study submissions or contracts review and budget negotiation or in related field such as where submissions or contract or legal document review is a primary part of you role, but required in Medical Device area.
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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