Clinical Trial Manager II

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.

What you will be doing:

• • Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
  • Leads Local Study Team consisting of CRA(s), CTA(s), for assigned study/studies
  • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
  • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
  • Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
  • Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with SOPs.
  • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
  • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
  • Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
  • Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
  • Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP

You are:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Solid experience in Development Operations (CRA, SrCRA) or other related fields
• Excellent verbal and written communication skills
• Solid experience with Oncology Trials

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.