Clinical System Analyst 2

2 months ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of the Position

The candidate will manage design, develop, implement, validate, maintain, and/or support clinical systems used by Clinical Affairs team. . The candidate will have an understanding of system design, development, implementation, validation and administration processes for Clinical systems.

Essential Job Duties 

  • Understand Clinical systems (pertaining to CTMS and eTMF) which includes design, creation and lifecycle management of data collection, validation, reporting specification and usage guidelines.
  • Understand CRF/study design and interpret protocol requirements to efficiently manage the system .
  • Create project specifications from stakeholders.
  • Configure system for a new/existing study using existing templates and/or project specifications.
  • Create validation of system at a study level including developing custom study requirements, test scripts, and UAT documentation.
  • Execute User acceptance testing for assign project in the system.
  • Administration of existing systems for multiple studies simultaneously.
  • Provide system support for study operations and analysis groups with standard and custom reports .
  • Training users on systems. Includes creation of training documentation and running training sessions for end users.
  • Data cleaning and review of reported data in a system. Including compliance review, trend review, user access review.
  • Manage post-go live issues and requests for the system.
  • Managing activities for multiple studies simultaneously in a dynamic environment.
  • Contribute to development and/or maintenance of departmental operating procedures for system group.
  • Proactive in understanding company needs/priorities and able to independently seek solutions.
  • Works on significant and unique issues in critical situations and able to provide solutions proactively.

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