Clinical Data Manager

Intuitive•Sunnyvale, CA

10h

About The Position

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.

Requirements

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.

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.