[Hiring] Principal Clinical System Designer @ICON plc

Role Description

We are currently seeking a Principal Clinical System Designer to join ICON’s Full-Service IOD Clinical Data Systems team. As a Principal Clinical System Designer at ICON, you will play a pivotal role in designing and implementing advanced clinical systems that enhance trial design and execution. You will also assess, develop, and oversee the training, mentoring, performance, and delegated activities of study team members, including leading clinical system design training and related processes.

What you will be doing:

• Acts as the primary point of contact during study build for complex questions by the project team.
• 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 Clinical System Lead (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.
• Provide refresher training to junior level CSL team members as required.
• Review the activity and progress of team members who have been delegated activity.
• Organizes and creates training and oversees the administration of training and mentoring for junior levels.
• Leads the development of materials for the bid defense process and client demonstrations and participates in industry meetings as a representative of ICON.
• Travel (approximately 10%) domestic and/or international.

Qualifications

• 8+ 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 Medidata Rave or Veeva EDC.
• Excellent functional knowledge of CRF design tools and ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols.
• Leadership and mentoring skills.
• Experience with bid defense meetings (preferred).
• Excellent written and verbal communication skills.
• Bachelor’s Degree in a relevant field.

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.