Principal Clinical System Designer

🕒 September 22

🌐 Colombia, Mexico – Remote

🇨🇴 Colombia – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🔴 Lead

✍️ Designer

👻 Ghost score 37%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 51 days.
• Jobs at this company usually fill in 21 days.
• Reposted once.
• No salary listed.

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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

• Act as the primary point of contact during study build for complex questions from the project team • 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 • Lead eCRF and other specification review meetings • Utilize and modify library edit checks for 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 Clinical System Lead • Support the Clinical System Lead with timeline negotiation and study decision-making • Assess impacts of post-production database changes and compile change management documentation • Drive post-production database changes and releases into production • Provide refresher training to junior Clinical System Lead team members • Review delegated activity and team-member progress • Organize and create training and oversee training and mentoring administration for junior staff • Lead materials development for bid defense processes and client demonstrations • Participate in industry meetings as an ICON representative • Travel approximately 10% domestically and/or internationally

🎯 Requirements

• 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 • 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 • 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

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