Clinical System Analyst III

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.

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.

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-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.