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Clinical Data Manager jobs in United States
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Intuitive · 15 hours ago

Clinical Data Manager

Intuitive is a pioneer in robotic-assisted surgery dedicated to enhancing minimally invasive care. The Clinical Data Manager will oversee clinical databases for studies and manage various data types, ensuring compliance with departmental procedures and quality metrics.
Health CareManufacturingMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Supervise electronic imaging software system design, testing, and implementation, as well as management of outside vendor(s) providing digital imaging software solutions. Serve as the Sponsor main point of contact for all imaging data acquisition activities outsourced to external clinical vendors (i.e. CROs, Clinical Imaging Software vendors, ePROs Software vendors, etc
Develop and maintain data organizational structures for video, digital pathology, DICOM, and other imaging datatypes
Follow a project-specific data management plan that includes oversight, quality checks, and data management. Ensure that the processes of data collection, validation, reporting specifications, and usage guidelines comply with study-specific requirements
Understand CRF design and interpret protocol requirements to efficient clinical database design
Create, oversee, and approve clinical databases design specifications
Experience with validation of EDC systems, clinical and imaging database systems at a study level including experience developing study requirements, test scripts, and UAT documentation
Administration of existing clinical databases and systems for multiple studies simultaneously
Coordinate with cross-functional teams, including clinical operations, CRO, Image process vendor, independent endpoint Data Review Committee, biostatistics, and IT
Manage data management timelines and deliverables. Oversee outsourced activities including independent rater sessions and Data Review Committees for imaging clinical trials. Develop protocols and procedures for the Data Review Committee to evaluate data discrepancies and trends
Facilitate regular meetings of the Data Review Committee to review data quality metrics and address any issues
Implement ongoing data quality metrics and dashboards to monitor the performance of data management processes
Collaborate with stakeholders to identify key performance indicators (KPIs) for data quality and ensure they are met throughout the study. 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
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

Qualification

EDC system experienceData management experienceGood Clinical PracticesMedical device knowledgeSAS software experienceInterpersonal skillsTeamworkEffective written communication

Required

Minimum BSc/BA in a scientific or medical field
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 (e.g., Medidata Rave, Veeva, etc.)
Experience both adhering to set operating procedures and creating new procedures as new needs arise
Excellent Interpersonal skills
Work well in a team environment
Work independently to carry out tasks with minimal guidance
Effective written communication and interpersonal skills
Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
Expertise with the collection and review of medical images and surgical procedure videos and pathology reports

Preferred

Experience with surgical studies
Experience with Investigational Drugs studies
Experience with Fluorescence Imaging Studies
Desired to have experience with SAS software
Desired to have medical knowledge as pertaining to medical devices for surgery

Company

Intuitive

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Intuitive designs and manufactures robotic-assisted surgical systems.

H1B Sponsorship

Intuitive has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)

Funding

Current Stage
Public Company
Total Funding
$5M
Key Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M

Leadership Team

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Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
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Myriam Curet
Executive Vice President & Chief Medical Officer
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Company data provided by crunchbase