Associate Clinical System Designer

4 weeks ago

Swansea, United Kingdom Icon plc Full time

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.

Associate Clinical System Designer
- The Associate Clinical System Designer uses technical, industrial, and interpersonal skills, with full support from project team leads and people leader, to interpret clinical protocols and customer requirements in order to create clinical data management system (CDMS) designs and non-CDMS component specifications (including electronic Case Report Forms (eCRFs), dynamic eCRF functionality and eCRF edit checks) to meet the needs of the customer and the clinical trial. Responsible for optimal design decisions and the utilization of ICON/client specific standards.
- Functional Knowledge:

- Basic functional knowledge of at least one clinical data management system and CRF design tool.
- Ability to interpret low complexity clinical trial protocols and protocol amendments.

Business Expertise:

- Acts as a point of contact during study build for assigned projects for design related questions by the project team.
- Read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks during set-up, maintenance and close-out of the study.
- Tracks and keeps functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner.
- With support, consolidates and completes the high-level system requirements documents and facilitates their review.
- Copies and modifies CRFs from standard libraries and other studies under specific instruction.
- Assist with development of Custom CRF screens, Edit Check and Dynamic Check specification documents, using prototyping methodologies as needed.
- With support, performs quality control peer reviews of database related specifications as needed and records comments appropriately.
- Supports more senior project leads in performing eCRF and other specification review meetings
- Other responsibilities may be assigned as required

Leadership:

- Ability and willingness to assist team members.
- Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs.
- Travel (approximately 0 %) domestic and/or international
- Typical years of experience 0-1. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated

Problem Solving:

- Problems are varied but similar. Solves problems using defined procedures or precedence.

Impact:

- Supports the achievement of goals through personal effort in own work area. Impact is focused on the immediate delivery of tasks.

Work is assessed regularly under guidance and direction.
Interpersonal Skills:

- Basic written and oral communication and presentation skills.
- Comfortable with inter/cross-team communication.
- 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.
- #LI-CL4

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