Study Start Up Associate I/II/Sr. - Regulatory Submissions

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.

The Role
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 trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
* Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
* Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager - Central Services or Designee.

* Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.

What you need for Study Start Up Associate I - Regulatory Submissions

* A high school diploma or local equivalent
* Bachelor's Degree preferably in Life Sciences
* Minimum of 1 years' experience or understanding of clinical study start up requirements and activities.
* Experience of Clinical Trial operations and meeting regulatory guidelines
* Proficient project management skills.

What you need for Study Start Up Associate II - Regulatory Submissions
* A high school diploma or local equivalent
* Bachelor's Degree preferably in Life Sciences
* Minimum of 2 years' experience or understanding of clinical study start up requirements and activities.
* Experience of Clinical Trial operations and meeting regulatory guidelines
* Proficient project management skills.

What you need for Sr. Study Start Up Associate - Regulatory Submissions
* A high school diploma or local equivalent
* Bachelor's Degree preferably in Life Sciences
* Minimum of 3 years' experience or understanding of clinical study start up requirements and activities.
* Experience of Clinical Trial operations and meeting regulatory guidelines
* Proficient project management skills.

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.