Senior Clinical Systems Specialist

Senior Clinical System Specialist

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.

General Summary:

Uses technical, industry, and interpersonal skills to develop, and oversee the execution of, User Acceptance Test (UAT) plans for clinical systems, with a focus on IRT and eCOA (ePRO and eConsent). This may include, but is not limited to, performing reviews of the User Requirements Specification (URS) and UAT deliverables (UAT Plan, UAT Test Cases, UAT Report), following the UAT process, and training testers in UAT execution.

The Role:

• Tests the components of at least one clinical system from a recognized vendor.

• Provides appropriate notifications and feedback on the URS, UAT requirements, UAT deliverables, and results of testing.

• Functions as subject matter expert on IRT for clinical teams.

• Develops and maintains clinical system UAT standards (SOP and template).

• Organizes and creates the administration of training and mentoring for junior levels.

• Provides oversight during the execution of UAT by supporting UAT coordination, execution, and error resolution and liaising with internal and external stakeholders.

• Collaborates with sponsor, external vendors, and internal functions to provide feedback in the development of UAT plan.

• Organizes all UAT activities on a group or program of studies; ensuring consistency of approach and re-use of test plans and cases between studies where applicable.

• Assists in training and mentoring of junior levels.

• Participates in company initiatives as directed by functional management.

To be successful in the role, you will have:

• Good knowledge of the software development life cycle (SDLC): reviewing requirements, testing, documentation, and deployment for any systems on which the clinical system UAT team participates

• Prior pharmaceutical or CRO industry experience

• Ability to interpret URS and clinical study protocols

• Good attention to detail

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.

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