Clinical System Analyst III

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

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 (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)

• 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.

Qualifications

Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)

• 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.

Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)

• BS/BA in a scientific or medical field

Working Conditions (As applicable - Any physical requirements for the job.  If not applicable, state “none”)

None

Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)

• 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.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID