Clinical Data Manager

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

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.
• Program/Configure eCRFs, Edit Checks, Visits and Schedule of Events in EDC system.
• 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.
• Assist in defining and creation of data listings, including programming software to generate listings.
• 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

Qualifications

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.

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-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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

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.