Role Description
We are currently seeking a Clinical System Designer I to join ICONβs Full-Service IOD Clinical Data Science team. As a Clinical System Designer I at ICON, you will play a pivotal role in designing and implementing advanced clinical systems that enhance trial design and execution.
What you will be doing:
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Leading the design and development of clinical systems, ensuring alignment with study protocols and operational needs
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Consolidates and completes the high-level system requirements documents and manages their review
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Responsible for copying and modifying CRFs from standard libraries and other studies
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Provides support and review for the re-use of library items
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Responsible for development of custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed
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Performs quality control peer reviews of database related specifications as needed and records comments appropriately
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Lead eCRF and other specification review meetings
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Utilizes edit checks from the appropriate library and modify the library edit checks to meet trial specific requirements
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Programs more complex dynamic checks and discrepancy edit checks to meet trial specific requirements
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Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL
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Support the CSL in negotiation of timelines and decision making on the study
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Assist in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads
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Drive the post-production database changes and release into production
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Provide refresher training to junior team members as required
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Review the activity and progress of team members who have been delegated activity
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Travel (approximately 10 %) domestic and/or international
Qualifications
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1+ years of experience in the design and implementation of clinical systems within the clinical research industry
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Expertise in data analysis and interpretation or Database Development, with proficiency in clinical data management systems and software
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Knowledge of at least 1 Clinical Data Management System (Medidata Rave, Veeva EDC, etc.)
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Functional knowledge of CRF design tools and ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols
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Excellent written and verbal communication skills
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Bachelorβs Degree in a relevant field
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Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above
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All employees must read, write, and speak fluent English and host country language
Requirements
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Please submit all applications in English
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Benefits
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Competitive base salary and performance related incentives
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Health and wellbeing programmes including medical, dental, and vision coverage where applicable
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Retirement and pension plans
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Life assurance and disability coverage
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Employee assistance programmes and wellbeing resources
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Learning and development opportunities through structured training and career pathways
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Benefits may vary depending on role and location