Senior CTA

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 the Senior CTA will develops/maintains study documents and utilizes company systems to manage  clinical biomedical studies. Provides administrative  support to project team members in clinical operations and project management. Works with the project team to ensure that projects are completed in accordance with contract and client

expectations. Completes project management  tasks as assigned by the study project manager/project directo r.

Project management  tasks will provide opportunities to broaden exposure to project management activities and to develop core project management skills.

Responsibilities:

• Organizes project team and client meetings including scheduling, creating meeting materials, binders, agendas and meeting minutes, etc.
• Assumes project management tasks as assigned by the study project manager/project director with final
• approval of deliverables completed by the study project manager/project director.
• Organizes study information and supplies. Generates and maintains organizational  charts, team calendar, newsletters, mass mailings, project specific information including but not limited to: process flow charts, contact lists, holiday lists, study website, mailing labels. Tracks, dispatches and maintains study supplies following applicable company processes.
• Establish and maintain the CTMS and TMF systems.
• Manages internal and client project reporting. Generates and reviews for accuracy reports to facilitate project status and financial reporting. Completes system updates and queries.
• Supports project manager with financial tasks. Has oversight of purchase order process including creating and processing purchase orders and processing study invoices. May process Investigator payments.
• May support preparation of study files by maintaining and distributing  project documents. Ensu res
• documents within the electronic trial master file comply with filing/naming guidelines and have the correct status.
• Uses the learning management system to assign project specific training to team members and tracks training compliance.

You are:

Passionate and responsible.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• BA/BS or equivalent or any relevant and qualifying training with a minimum of 2 years of relevant clinical trial experience
• Expert knowledge of applicable systems/processes including CFR, GCP/ICH guidelines, SOPs
• Proficiency in using applicable business applications including word processing, spreadsheet, presentation programs
• Ability to use basic principles of timeline management, project financials, and risk management
• Robust knowledge of the company’s industry and service offerings
• Working knowledge of relevant regulations
• Working knowledge of drug/patient safety procedures and regulations
• Familiarity with medical terminology
• Read, write and speak fluent English.
• General knowledge of risk management
• Advanced knowledge of several functional activities, use of functional specific processes or systems, and/or therapeutic knowledge based on previous work assignments
• Understanding of basic roles within the clinical research organization including but not limited to clinical operations, biometrics, regulatory and drug safety

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.