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Clinical System Designer

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Research & Development
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1803674 Requisition #
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  • 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

 

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