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.
Working fully embedded within one of our pharmaceutical clients, with the support of ICON right behind you, you’ll be at the heart of our client’s innovation. The sponsor is a global fast-growing biotech company with one of the most exciting product pipelines in the industry.
This global client develops breakthrough innovative medicines to improve and extend people’s lives with targeted therapies for cancer. Join the fight against cancer at this sponsor who is running more than 60 clinical trials globally in the area of solid tumors and hematologic cancers.
- Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned.
- Distribute and collect CDAs for potential study sites.
- 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 (SIS)/ICFs.
- Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.
- Responsible for the timely follow up for queries made by EC/competent authority (CA).
- Coordinate and create documents and material needed to support SIV
- Responsible for the dispatch, negotiation, execution, and tracking of contract with sites and other sites, as appropriate.
- Attend study team meetings as required, including Kick-Off Meeting.
- Responsible for the collection and maintenance of the current regulatory/CA and EC submission information and similar information for other related organizations in the assigned countries and update relevant information system.
- Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable.
- Develop and maintain effective relationships with local, regional, and country authorities.
- Comply with all department requirements regarding information provision and status updating and reporting
- Prior experience of working in site start, from either a pharmaceutical company or a CRO environment for at leat 3 year
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- Fluent in English plus Spanish.
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.