Clinical Data Manager

Primary Function of Position :

The candidate will manage implement maintain and support clinical databases related pre-market clinical studies / registries. The candidate will have an understanding of data review oversight and management systems. The candidate will be responsible for adhering to the required departmental operating procedures for clinical investigations. 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 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.

Qualifications : Qualifications

Skill Experience Education Training :

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 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 experience with SAS software.

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.

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 employeeswho 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 governments 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 employeesstart 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.

Remote Work : No

Employment Type : Full-time

Key Skills

SQL,Data Collection,GCP,Master Data Management,R,Data Management,Clinical Trials,User Acceptance Testing,Data Warehouse,SAS,Oracle,Data Analysis Skills

Experience : years

Vacancy : 1