Manager, Global Data Management

Primary Function of Position:

This position is responsible for managing the global data management team in supporting data management activities for clinical investigations across multiple regions. It partners with the clinical operations team to define, collect, review and export clinical data based on clinical protocols according to relevant regulatory requirements. This position contributes to overall success by providing tactical and strategic leadership while fostering team development in a complex scientific environment.

Essential Job Duties:

• Manage global data management team in supporting clinical investigations in multiple regions including US, EU and APAC
• Working with Clinical Affairs teams in multiple regions/time zones supporting their projects
• Manage the development of project specific data management essential documentation (Data Management Plan, database specification, validations documents, etc.)
• Manage the design, implementation and validation of clinical databases based on existing data management standards and requirements
• Manage the creation/maintenance of QMS documentation for all data management processes.
• Manage the development of the data management team through talent development and effective team management in a dynamic environment supporting multiple business units.
• Manage the generation and distribution of data management metrics/dashboards/KPIs
• Oversee and manage data integrity and quality control procedures to ensure high quality output.
• Manage data management resources and budgets in support of global corporate clinical investigation goals
• Provide team leadership and support during implementation of databases, vendor upgrades and managing post-go-live issues and requests
• Partner with external service providers (CROs, EDC vendors) to meet business goals
• 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.
• Contributes to departmental workload, timelines, resource and budget planning.
• Facilitate departmental goal setting and process improvement projects

Qualifications:

• Minimum BS or MS in scientific field
• Minimum of 8-10 years of data management experience with a proven track record working in the medical device industry.
• Minimum of 2-3 years of experience in direct people management, ideally on a data management team.
• Advanced working knowledge of Clinical database applications such as EDC and CTMS.
• Excellent understanding of CRF design and interpretation of protocol requirements to efficient EDC design.
• Excellent understanding of regulatory requirements for clinical investigations
• Excellent Interpersonal skills
• Work well in a team environment
• Work independently to carry out tasks with minimal guidance
• Able to train and support end users through effective written communication and interpersonal skills.
• Experience working with outside service providers (CROs, EDC vendors, etc.) to manage aspects of data management activities for clinical investigations
• Must be able to travel up to 5%

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.