Clinical System Designer II

Clinical System Designer II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Clinical System Designer II to join ICON’s Full-Service IOD Clinical Data Science team. As a Clinical System Designer II at ICON, you will play a pivotal role in designing and implementing advanced clinical systems that enhance trial design and execution. Your expertise will be essential in driving innovation and ensuring that our clinical systems meet regulatory requirements and support operational efficiency.

Location:

• Mexico City (Office-Based with remote flexibility or homebased could be discussed)
• Colombia (home-based)

What you will be doing:

• 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 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

Your profile:

• 3+ years of experience in the design and implementation of clinical systems within the clinical research industry
• Expertise in data analysis and interpretation or Data Base Development, with proficiency in clinical data management systems and software
• Knowledge of at least 1 Clinical Data Management System (Medidata Rave, Veeva EDC, etc.)
• Excellent functional knowledge of Clinical Data Management 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
• 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.

* Please submit all applications in English *

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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