Clinical System Designer I
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Job Description
Clinical System Designer developing clinical databases, CRFs, and edit checks for ICON’s global healthcare intelligence and clinical research organization. Supporting trial delivery across Canada, Mexico, and Colombia.
Responsibilities:
- Design and develop clinical systems aligned with study protocols and operational needs
- Consolidate and complete high-level system requirements documents and manage their review
- Copy and modify CRFs from standard libraries and other studies
- Support and review the reuse of library items
- Develop custom CRF screens, Edit Check, and Dynamic Check specification documents using prototyping methodologies as needed
- Perform quality control peer reviews of database-related specifications and record comments
- Lead eCRF and other specification review meetings
- Utilize and modify library edit checks for trial-specific requirements
- Program complex dynamic checks and discrepancy edit checks
- Review ongoing activity to identify out-of-scope tasks and escalate them to the CSL
- Support the CSL with timeline negotiation and study decision-making
- Assess impacts of post-production database changes and compile change-management documentation
- Drive post-production database changes and releases into production
- Provide refresher training to junior team members
- Review activity and progress of delegated team members
- Travel approximately 10% domestically and/or internationally
Requirements:
- 1+ years of experience in the design and implementation of 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 (Medidata Rave, Veeva EDC, etc.)
- 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
- 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
- Applications must be submitted in English
- 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
- Travel (approximately 10 %) domestic and/or international
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