Clinical System Designer - Office based - Swansea, Dublin ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Role: Functional Knowledge:Excellent functional knowledge of CRF design tools and one clinical data management system, with basic understanding of another CDMS.Ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols.Business Expertise:Acts as the primary 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.Consolidates and completes the high-level system requirements documents and manages their review.Responsible for Copying and modifying CRFs from standard libraries and other studies.Provides support and review for the re-use of library items.Responsible for development of Custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed.Performs quality control peer reviews of database related specifications as needed and records comments appropriately.Lead eCRF and other specification review meetings.Creates and maintains standard libraries for all study components.Utilizes edit checks from the appropriate library and modifies the library edit checks to meet trial specific requirements.With assistance, may program dynamic checks and discrepancy edit checks to meet trial specific requirements.Assists in the development of materials for the bid defence process and client demonstrations and participates in industry meetings as a representative of ICON.Obtains required approvals for the release of system components to the live/production environment.Reviews all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL.Supports the CSL in negotiation of timelines and decision making on the study.Maintains and tracks meeting minutes, issues and decisions logs, and escalations where appropriate.Takes part in study kick off (internal and external) meetings as appropriate.Assists in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads.Other responsibilities may be assigned as required.Leadership:Ability and willingness to assist team members.Assesses the training needs of study team members on an ongoing basis.Provides refresher training to junior CSL level team members as required.Reviews the activity and progress of team members who have been delegated activity.Organizes and creates training and helps to oversee and administer training and mentoring for junior levels.Embraces and contributes to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs.Travel (approximately 10%) domestic and/or international.Typical years of experience 3+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated.Problem Solving:Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems.Assists with the development and implementation of improvements to CSD systems and processes.Impact:Contributes to the achievement of goals through personal effort and influence over others. Impact is focused on the achievement of short- to medium-term goals.Interpersonal Skills:Strong written and oral communication and presentation skills.Strong inter/cross-team communication 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.
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