Principal Clinical System Designer

🔥 2 minutes ago

🌐 Colombia, Mexico – Remote

🇨🇴 Colombia – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🔴 Lead

✍️ Designer

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead the design and development of 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 appropriately • Lead eCRF and other specification review meetings • Use and modify library edit checks to meet 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 negotiations and study decision-making • Assess impacts of post-production database-related changes and compile change-management documentation • Drive post-production database changes and release them into production • Travel approximately 10% domestically and/or internationally

🎯 Requirements

• 4+ 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 • 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 • 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 • Must read, write, and speak fluent English and host country language • Must have the legal right to work in the country where the role is based • Applications must be submitted in English

🏖️ 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