Description
ICON is seeking a Senior Clinical System Designer to join its Full-Service IOD Clinical Data Science team. As a Senior Clinical System Designer at ICON, you will play a pivotal role in designing and implementing advanced clinical systems that enhance trial design and execution.
Responsibilities:
- Leading the design and development of clinical systems, ensuring alignment with study protocols and operational needs
- Consolidating and completing high-level system requirements documents and managing their review
- Copying and modifying CRFs from standard libraries and other studies
- Providing support and review for the re-use of library items
- Developing custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed
- Performing quality control peer reviews of database related specifications as needed and recording comments appropriately
- Leading eCRF and other specification review meetings
- Utilizing edit checks from the appropriate library and modifying them to meet trial specific requirements
- Programming more complex dynamic checks and discrepancy edit checks to meet trial specific requirements
- Reviewing all activity on an ongoing basis to identify out of scope tasks and bringing them to the attention of the CSL
- Supporting the CSL in negotiation of timelines and decision making on the study
- Assisting in assessing impacts of post-production database related changes and compiling change management documentation for review by project team leads
- Driving post-production database changes and releasing them into production
- Travelling approximately 10% domestically and/or internationally
Requirements:
- 5+ years of experience in designing and implementing clinical systems within the clinical research industry
- Expertise in data analysis and interpretation or Database Development, with proficiency in clinical data management systems and software
- Knowledge of at least 1 Clinical Data Management System (e.g. Medidata Rave, Veeva EDC)
- Excellent functional knowledge of CRF design tools and ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols
- Excellent written and verbal communication skills
- Bachelor's Degree in a relevant field
Rewards & Benefits:
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways