[Hiring] Senior Clinical System Designer @ICON plc

Role Description

As a Principal Clinical System Designer at ICON, you will design and implement advanced clinical systems that enhance trial design and execution.

• Leading the design and development of clinical systems, ensuring alignment with study protocols and operational needs.
• Consolidates and completes the high-level system requirements documents and manages their review.
• Responsible for copying and modifying CRFs from standard libraries and other studies.
• Provides support and review for the re-use of library items.
• Responsible for development of Custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed.
• Performs quality control peer reviews of database related specifications as needed and records comments appropriately.
• Lead eCRF and other specification review meetings.
• Utilizes edit checks from the appropriate library and modifies the library edit checks to meet trial specific requirements.
• Programs more complex dynamic checks and discrepancy edit checks to meet trial specific requirements.
• Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL.
• Support the CSL in negotiation of timelines and decision making on the study.
• Assist in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads.
• Drive the post-production database changes and release into production.
• Travel (approximately 10%) domestic and/or international.

Qualifications

• 3+ years of experience in the design and implementation of clinical systems within the clinical research industry.
• Expertise in data analysis and interpretation or Data Base Development, with proficiency in clinical data management systems and software.
• Knowledge of at least 1 Clinical Data Management System (Medidata Rave, Veeva EDC, etc.).
• 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 host country language.

Requirements

• Please submit all applications in English.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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.

Company 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.