AbbVie Clinical System Designer in Lake County, Illinois

Clinical System Designer

New

USA, Illinois, Lake County

Research & Development

Requisition #1803674

  • 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.

Basic:

Minimum Education

  • 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