Clinical System Designer

1 month ago

Shefford, Central Bedfordshire, United Kingdom ICON Plc Full time
The Role:

As a Clinical System Designer at ICON plc, you will play a crucial role in shaping the future of clinical development. Our team is dedicated to advancing clinical research, and we are seeking a talented individual to join us in this mission.

Functional Knowledge:
  1. Excellent functional knowledge of CRF design tools and one clinical data management system, with a 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. Reads, ensures understanding, and adheres to the study protocol, contract, and scope of work for all tasks 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.

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