Clinical System Designer II

Functional Knowledge:
• Excellent functional knowledge of CRF design tools and one clinical data management system, with basic understanding of another CDMS.
• Ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols.
Business Expertise:
• Acts as the primary point of contact during study build for assigned projects for design related questions by the project team.
• Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
• Tracks and keeps functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner
• 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
• Creates and maintains standard libraries for all study components.
• Utilizes edit checks from the appropriate library and modify the library edit checks to meet trial specific requirements.
• With assistance, may program dynamic checks and discrepancy edit checks to meet trial specific requirements.
•Assists in the development of materials for the bid defence process and client demonstrations and participate in industry meetings as a representative of ICON.
• Obtains required approvals for the release of system components to the live/production environment.
• 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 time lines and decision making on the study
• Maintain and track meeting minutes, issues and decisions logs, and escalations where appropriate
• Take part in study kick off (internal and external) meeting as appropriate
Assist in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads.
• Other responsibilities may be assigned as required
Leadership:
• Ability and willingness to assist team members.
• Assess the training needs of study team members on an ongoing basis
• Provide refresher training to junior CSl level team members as required
• Review the activity and progress of team members who have been delegated activity
• Organizes and creates training and helps to oversee and administer training and mentoring for junior levels.
• Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs.
• Travel (approximately 10 %) domestic and/or international
• Typical years of experience 3+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated
Problem Solving:
•Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems.
• Assists with the development and implementation of improvements to CSD systems and processes.
Impact:
• Contributes to the achievement of goals through personal effort and influence over others. Impact is focused on the achievement of short- to medium term goals.
Interpersonal Skills:
• Strong written and oral communication and presentation skills.
• Strong inter/cross-team communication skills.

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