AbbVie Clinical System Designer in Lake County, Illinois
Clinical System Designer
USA, Illinois, Lake County
Research & Development
Manages design activities related to core Data Sciences trial-specific systems, including the facilitation of cross-functional team meetings to review systems design
Creates and delivers system specifications for core Data Sciences trial-specific systems
Creates test plans and reviews test results to ensure systems meet protocol requirements
Acts as primary liaison with outsourced trial support teams
Ensures trial data integrity and quality
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Creates specifications and test plan scripts for Data Sciences trial-specific systems (e.g., EDC, IRT, ePRO) for all assigned trials during start-up and during trial conduct if changes are needed
Manages the work of the systems programmers and ensures systems are built in alignment with protocol and cross functional team feedback.
Facilitates systems review meetings and serves as a liaison between the cross functional team and the respective systems programmers
Effectively communicates progress and expectations around the System Design Group process
Serves as a subject matter expert for Data Sciences trial-specific systems
Position Accountability / Scope
Reports to Manager/Associate Director, Data Science
Accountable to correctly implement the design of the protocol into the Data Sciences trial-specific systems specifications for all assigned trial
Accountable to produce a system test plan that, when executed as designed, will produce a clinical-trial system that is fit for purpose and adequate for statistical analysis.
Accountable for the preparation and facilitation of Clinical Technology review meetings with cross-functional team members from Statistics, Statistical Programming, Clinical Program Development, etc
Accountable for supporting and utilizing Data Sciences policies and procedures.
- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent is required. Master’s degree is desired
Minimum Experience / Training Required
Must have 2+ years of direct data management experience or 4+ years of experience in a similar technical environment
Must have experience designing systems and creating system specifications.
Must have demonstrated experience in influencing teams during the design, conduct, and completion of trials.
Demonstrated effective communication skills.
Must demonstrate analytical skills and ability to identify signals and potential issues with clinical systems, and development of plans to address