Clinical Systems Designer EDC eCRF San Francisco

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Clinical Systems Designer job San Francisco EDC RAVE eCRF
full-time on-site position in San Francisco Bay Area
no relocation or sponsorship available
clinical systems designer job San Francisco

Position overview:
these qualities:

Data management experience
Understanding of EDC build (preferably RAVE)
Familiar with industry standard eCRFs (preferably for oncology studies)
Previous Interaction with Clinical Operations and understanding of Clin Ops roles will be helpful

The person in this role will need to work with study teams as they build the clinical database/eCRFs for the study. Knowledge of the above will help the person in making the best choices when creating the study-specific specifications. The person will need to show leadership, commitment to ‘standards’, and be able to hold their own when Clinical personnel want to insert their preferences.


Position Overview
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

Key Responsibilities
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 processes
Serves as a subject matter expert for Data Sciences trial-specific systems
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Position Accountability
Reports to Manager/Associate Director, Data Sciences
Accountable for implementation of the design of the protocol into the Data Sciences trial-specific systems specifications for all assigned trials
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.
clinical systems designer job San Francisco

Equal Opportunity Employer Minorities/Women/Veterans/Disabled


Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent is required. Master’s degree is desired
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
clinical systems designer job San Francisco

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