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Clinical System Designer
2 months ago
As a Clinical System Designer at ICON plc, you will play a crucial role in shaping the future of clinical development. Our team is dedicated to advancing clinical research and providing outsourced services to pharmaceutical, biotechnology, medical device, and government organizations.
Key Responsibilities:- Design and develop clinical data management systems, utilizing CRF design tools and CDMS.
- Plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols.
- Act as the primary point of contact during study build for assigned projects, addressing design-related questions from the project team.
- Read, understand, and adhere to study protocols, contracts, and scope of work for all tasks during setup, maintenance, and close-out of the study.
- Track and inform functional management and project management of any issues affecting project target dates, scope, or budget.
- Consolidate and complete high-level system requirements documents and manage their review.
- 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 appropriately.
- Utilize edit checks from the appropriate library and modify library edit checks to meet trial-specific requirements.
- Assist in assessing the impact of post-production database-related changes and compile change management documentation for review by project team leads.
- Assess training needs of study team members and provide refresher training to junior CSL level team members as required.
- Organize and create training, overseeing and administering training and mentoring for junior levels.
- Travel (approximately 10%) domestic and/or international.
- Assist with the development and implementation of improvements to CSD systems and processes.
At ICON plc, we are committed to developing our employees in a continuous learning culture. Our focus is to provide a comprehensive and competitive total reward package that comprises an excellent level of base pay, variable pay, and recognition programs. We also offer best-in-class employee benefits, supportive policies, and wellbeing initiatives tailored to support you and your family at all stages of your career.
