CDC 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.

The Clinical System Developer uses technical, industrial, and interpersonal skills to program the clinical data management system (CDMS) and Non-CDMS components (including dynamic electronic case report form (eCRF) checks, edit checks, custom programs and integrations) and to develop and maintain programs required for handling external vendor data.

Primary Responsibilities
• Reviews the design and assembly of eCRFs.
• Reviews and comments on Edit Check Specifications (ECS) and copies and makes modifications to library edit checks when required.
• Responsible for the programming of dynamic eCRF functionality and edit checks according to defined specifications.
• Responsible for development of custom programs and Data Validation Outputs (DVO) and review of the developed outputs to ensure they meet the agreed specifications.
• Reviews Data Transfer Specifications (DTS) and provides constructive feedback. Creates and maintains external data handling instructions and import program specifications. Receives and manages regular imports of data, including blinded and unblinded data.
• Contributes to the management of trial deliverables and project scope. Tracks and communicates project development status and worked units to the project team and functional management.
• Actively participates in internal meetings and provides constructive feedback to peers, team leads and managers, and functional management.
• Responsible for raw data transfers out of the CDMS.

To be successful in this role you will have:

• Solid knowledge of the requirements, capabilities, and limitations of at least one clinical data management system
• Understands pharmaceutical environments and clinical data management system
• Good written and oral communication and presentation 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.