Lead Clinical Systems Designer - Remote (10% Travel)

Icon; Bogotá ciudad; Remote; COP 291,290,000 - 485,484,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life assurance

Flexible benefits

Job summary

ICON is a global healthcare intelligence and clinical research organisation seeking a Senior Clinical System Designer for Colombia and Mexico with remote options. You will lead the design and development of clinical systems, ensure alignment with study protocols, and manage high-level system requirements documents.

You will also develop Custom CRF screens, edit checks, and prototype-driven specifications, review library items, and support post-production changes.

Qualifications

• 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.

Responsibilities

• 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
• Travel (approximately 10%) domestic and/or international

Skills

Clinical systems design

Data analysis

CDMS knowledge

English fluency

Tools

Medidata Rave

Veeva EDC

Job description

ICON is a global healthcare intelligence and clinical research organisation seeking a Senior Clinical System Designer for Colombia and Mexico with remote options. You will lead the design and development of clinical systems, ensure alignment with study protocols, and manage high-level system requirements documents.

You will also develop Custom CRF screens, edit checks, and prototype-driven specifications, review library items, and support post-production changes.