Project Associate
- Warsaw
- ICON Full Service & Corporate Support
- Project/ Program Management
- Office Based
Senior Talent Acquisition Business Partner
- Full Service Division
About the role
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.
The Role:
We are seeking a highly organized and detail-oriented Project Associate to join our Global Regulatory Affairs team. The ideal candidate will be responsible for submitting and following up on initial and amended clinical trial applications via the EU portal Clinical Trial Information System (CTIS).
Responsibilities :
- Day-to-day management of assigned clinical trials in CTIS
- Monitoring of CTIS notices and alerts, receipt of RFIs and related submission timelines
- Upload and submit all types of prepared clinical trial applications through CTIS including but not limited to initial applications, responses to RFIs, amendments, notifications, substantial modifications, non-substantial modifications, corrective measures, ad hoc assessments. etc.
- Ensures smooth running of all CTIS processes
- May enter clinical trial application data
- Works closely with applicable Functional Leads to meet submission timelines
- Creates outputs of submissions and timetable creation from CTIS and filing into applicable company systems
Qualifications:
- Bachelor’s degree in Life Sciences or related field.
- Familiarity with the EU Clinical Trial Information System (CTIS) is strong advantage.
- Strong organizational and administrative skills.
- Excellent attention to detail and ability to manage multiple tasks simultaneously.
- Effective communication and teamwork skills.
- Proficiency in Microsoft Office and other relevant software.
- Fluency in Polish and English
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.
LI-MK1
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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