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Clinical System Designer

2 months ago

Shefford, Central Bedfordshire, United Kingdom ICON Plc Full time
Clinical System Designer - ICON Plc About ICON Plc 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. Our Work From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. 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. The Role Functional Knowledge:
  1. Excellent functional knowledge of CRF design tools and one clinical data management system, with basic understanding of another CDMS.
  2. Ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols.
Business Expertise:
  1. Acts as the primary point of contact during study build for assigned projects for design related questions by the project team.
  2. Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
  3. 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.
  4. Consolidates and completes the high-level system requirements documents and manages their review.
  5. Responsible for development of Custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed.
  6. Performs quality control peer reviews of database related specifications as needed and records comments appropriately.
  7. Utilizes edit checks from the appropriate library and modifies the library edit checks to meet trial specific requirements.
  8. With assistance, may program dynamic checks and discrepancy edit checks to meet trial specific requirements.
  9. Assists in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads.
  10. Assesses the training needs of study team members on an ongoing basis.
  11. Provides refresher training to junior CSL level team members as required.
  12. Organizes and creates training and helps to oversee and administer training and mentoring for junior levels.
  13. Travel (approximately 10%) domestic and/or international.
  14. Assists with the development and implementation of improvements to CSD systems and processes.
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.