Clinical Data Manager

The candidate will manage design, development, implementation, validation, maintenance, and

support clinical databases related pre-market or post- market clinical studies/registries. The

candidate will be responsible for adhering to the required departmental operating procedures

regarding Data Management for clinical investigations. The position requires effective

collaboration with clinical operation teams, supporting project goals, and ensuring high-quality

research and database development

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)

• Develop project specific data management plan that includes design, creation and

lifecycle management of data collection, validation, reporting specification and usage

guidelines.

• Understand CRF design and interpret protocol requirements to efficient EDC design.
• Create clinical databases design specifications including edit check specifications.
• Experience with validation of EDCs at a study level including experience developing

study requirements, test scripts, and UAT documentation.

• Administration of existing EDC systems for multiple studies simultaneously.
• Provide clinical data management support for study operations and analysis groups

including the following.

o Assist in defining and creation of data listings, including programming software to

generate listings.

o Data specifications and/or process data transfers in preparation for statistical

review.

• Training users on EDC systems. Includes create of training documentation and running

training sessions for end users.

• Data cleaning and review of clinical data. Including query management and data listing

review.

• Manage post-go live issues and requests.
• Managing activities for multiple studies simultaneously in a dynamic environment.
• Contribute to development and/or maintenance of departmental operating procedures for

data management.

• 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 3-5 years of data management experience with a proven track record

working in a medical device/pharmaceutical industry.

• EDC system(s) experience (Preferably Medrio and Medidata Rave)
• 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)

• BSc/BA in a scientific or medical fiel

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 SAS software.
• Desired to have medical knowledge as pertaining to medical devices for surgery.
• 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 l…