Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a Senior Clinical System Designer at ICON, you will design and implement 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 negotiating timelines and making decisions 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.
- Traveling approximately 10% domestically and/or internationally.
Your Profile:
- 3+ 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 one Clinical Data Management System (e.g., Medidata Rave, Veeva EDC).
- Excellent functional knowledge of Clinical Data Management CRF design tools and ability to plan and design CDMS components directly from interpreting medium-complexity clinical trial protocols.
- Excellent written and verbal communication skills.
- Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
- All employees must read, write, and speak fluent English and the host country language.
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.
Benefits may vary depending on role and location.