Clinical System Designer
- 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
- A ccountable 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