Study Start Up Associate Ii
hace 1 semana
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.
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 interventional, late phase and medical device studies.
The Role
- Stay connected with Investigative sites and internal personnel regarding the status of regulatory documents
- 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.
- Accountable for countryspecific projects in study startup phase, cooperating with global SAL (Site Activation Lead who is overseeing all countries and being in direct client contact)
What you need
- A bachelor's degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred
- SSU experience is desirable but not required.
- Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.
- Fluency in local language and English is essential.
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.
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