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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Principal 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 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.
Your Profile:
- 4+ 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 interpretation of 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.