Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Clinical System Analyst III will manage the design, development, implementation, and support of clinical systems used by the Clinical Affairs team, ensuring efficient project specifications and system administration for multiple studies.
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/objectives and able to independently seek solutions
Works on significant and unique issues in critical situations and able to provide solutions proactively
Qualification
Required
Minimum of 2-5 years of experience with a clinical system with a proven track record working in a medical device/pharmaceutical industry
CTMS system(s) experience
Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
BS/BA in a scientific or medical field
Preferred
Desired to have experience with CTMS and eTMF tool both
Desired to have medical knowledge as pertaining to medical devices for surgery
Desired to have system knowledge as pertaining to development and validation of software
Excellent Interpersonal skills
Work well in a team environment
Work independently to carry out tasks with minimal guidance
Effective written communication and interpersonal skills
Benefit
Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
Intuitive designs and manufactures robotic-assisted surgical systems.
