Clinical Data Manager/Analyst

• As a Clinical Data Manager/Analyst in the Quantitative Sciences organization, you will be responsible for supporting and managing the collection, capture, quality, and integrity of data, from diverse sources, including electronic health records, eCRF, ePRO, digital health technologies including apps and sensors, digital biomarkers, advanced specialty labs, images, and others.
• You will plan, monitor, and manage across data streams from data capture through ingestion into Client platforms, 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.
• As a member of the Clinical Data Management team you will work with cross-functional colleagues to integrate the team’s work across Client and develop new models to enable efficient clinical data management activities at-scale to build our product offerings supporting sponsored clinical research and evidence generation with our external partners.

• Provide clinical data management support across a diverse portfolio of Client 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 study projects to incorporate cross-data stream checks, and ensure DMP is followed according to study design and requirements.
• Develop 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 electronic patient reported outcome (ePRO) design and annotation, edit rules/checks, query logic and data validations. As required, coordinate and communicate with internal partners and external vendors.
• Complete validation of database build, including but not limited to: developing test scripts, execution logs for validation, edit checks, data listings, data reconciliation and/or coding and validation summary report.
• Collaborate with cross-functional teams to monitor and provide data to support clinical operational activities and reports. Partner with Quantitative Sciences to develop and document data repository schema across data sources.

• 7+ years of data management and/or related work experience in a pharmaceutical, biotech, or medical device industry/company.
• Experience with Good Clinical Practices (GCP), Good Pharmacoepidemiology Practice (GPP), clinical research and medical product development, clinical trial processes and related regulatory requirements and terminology (e.g., 21 CFR Part 11, human subjects research).

• Experience with clinical databases i.e. EDC and EHR systems.
• Experience with using Fast Healthcare Interoperability Resources (FHIR) and/or working with the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM).
• Experience working with medical devices.
• Experience working with digital biomarkers.
• Fluency in CDISC, MedDRA and other health data standards.
• Basic to intermediate competency in SQL.
• Experience with R, python, SAS or other statistical tools is a plus. Basic knowledge of statistics.

• Bachelor's degree in health or science, or equivalent practical experience.
• Advanced degree in informatics, clinical research, or computer science preferred.

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