Clinical Data Manager

Primary Function of Position:

The candidate will manage the surgical imaging corelab(s), including the management of implementations, maintenance and ongoing support of clinical imaging databases related pre-market clinical studies/ and post market registries. The candidate will be involved in the preparation of images, source data packages and other related materials for ongoing Data Review Committee (s) meetings and related data verifications.

The candidate will have an understanding of data review, oversight, clinical data and surgical imaging management systems. The candidate will be responsible for adhering to the required departmental operating procedures for clinical investigations and/or for selected CRO(s) operating procedures for Intuitive Fluorescence Imaging clinical programs. The candidate will have experience managing a variety of different data types, including EDC data, video and imaging acquisition software, digital pathology, and DICOM data, etc. Ideal candidates will have had operational experience managing clinical trial digital assets, primarily video data, as well as oversight and QC of the data.

Roles and Responsibilities:

• Supervise electronic imaging software system design, testing (UAT), 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 Core Lab plan and 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/sCRF 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, data flow 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 creating 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 imaging data and study esource documents. 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

Skill, Experience, Education, Training:

• Minimum BSc/BA in a scientific or medical field
• Minimum of 3-5 years of Core Lab imaging data management and/or 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.) and other clinical trials databases and systems.
• Experience with surgical studies preferred.
• Experience with Investigational Drugs studies preferred.
• Experience with Fluorescence Imaging Studies preferred.
• 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.
• Desired to have medical knowledge as pertaining to medical devices for surgery.
• Expertise with the collection and review of medical images and surgical procedure videos and pathology reports.

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

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.