Clinical Data Manager/Analyst 2046 views

As a Clinical Data Manager/Analyst, you will be responsible for supporting and managing the capture, quality, and analysis of data, from diverse sources, including electronic health, eCRF, apps, sensors, and digital biomarkers, advanced specialty labs, images, and others. You will plan, monitor, and manage across data streams from data capture through ingestion into Verily repositories, ensuring data collected are of high quality, documented, and ordered to support planned and potential analyses and uses. You should be fluent in the use of technical and statistical tools that enable assessment and review of data.

Their team combines expertise in biology, chemistry, physics, medicine, engineering, computer science, and more to create interventions that exponentially improve patient care. They partner with leading life sciences, medical devices, and government organizations to enable fast development, meaningful advances, and deployment at scale. Their work spans many projects, including Project Baseline, the quest to map human health beginning with a 10,000 person observational study; Liftware, stabilizing utensil handles to aid individuals with hand tremor or limited mobility; and Debug, an effort to eradicate mosquito-borne disease with Sterile Insect Technique. For more information, please visit their website.

Responsibilities

• • Provide clinical data management support across a diverse portfolio of Verily clinical studies and a diverse range of data streams, including clinical data, sensor data, advanced molecular data, app data, and imaging data.
  • Develop innovative Data Management Plans (DMP), enhanced as required through the lifecycle of the study project to incorporate cross-data stream checks, and ensure DMP is followed according to study design and requirements.
  • Develop a Data Quality Plan, considering the full range of data sources, and perform specified validation and quality management activities. Build and develop databases (DB) to protocol objectives and specifications, inclusive of electronic Case Report Form (eCRF) and ePRO design and annotation, edit rules/checks, query logic, and data validations. As needed, coordinate and communicate with vendors.
  • Coordinate User Acceptance Testing (UAT) of Electronic Data Capture (EDC) build and validation documents, including but not limited to: test scripts, execution logs for UAT, edit checks, data listings, data reconciliation and/or coding and UAT summary report.
  • Monitor and provide data to Clinical Operations to support clinical operational activities and reports. Partner with Biostatistics to develop and document data repository schema across data sources.

Qualifications

Minimum qualifications:

• • Bachelor’s degree in health or science, or equivalent practical experience. Advanced degree in informatics, biostatistics, or computer science preferred.
  • 7+ years of data management and/or related work experience in a medical device or pharmaceutical industry/company.
  • Experience with Good Clinical Practices, clinical research and medical product development, clinical trial processes and related regulatory requirements and terminology.

Preferred Qualifications

• Experience with clinical data databases such as EDC and EHR systems.
• Fluency in CDISC, MedDRA and other health data standards.
• Basic to intermediate competency in SQL. Experience with R, Python or other statistical tools a plus.
• Fundamental knowledge of statistics.