Principal Clinical System Designer

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.

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.

Location: Remote or Hybrid

• Mexico
• Colombia

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 modify 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

Your profile:

• 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 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

* Please submit all applications in English *

#LI-TP1

#LI-Remote 

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply