Lead Data Manager

4 days ago

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Tempus Labs, Inc.

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Description

• Passionate about precision medicine and advancing the healthcare industry? • Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. • Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. • We're looking for an experienced Lead Data Manager to help us design and execute on clinical evidence studies with the mission of delivering personalized care to cancer patients. • Accountable for leading all data management activities for clinical studies, including: • eCRF development • Database build activities, including database development, edit check specifications and performance of user acceptance testing • Data collection, data cleaning and reporting • Document project-specific data management, data validation, data transfer and data entry guidelines to ensure appropriate, consistent, and efficient processing of data in collaboration with key stakeholders • Develop and execute data validation programs and generate queries on potentially discrepant data • Design, develop and execute programs to support data reporting, central monitoring, identification of patients and data transformations. • Responsible for the coordination and execution of the review and verification of all data collected for a project, including reconciliation of external data (e.g., central laboratories, local laboratories) to ensure all data is correct, complete, and logical • Interface with internal functional teams responsible for data quality and delivery to ensure a robust, quality regulatory-grade data pipeline • Responsible for documentation of activities, including development and maintenance of the data management project file and close out activities, including locking and archival of the final project database • Drive process improvement efforts and authorship and/or review of department SOPs

Requirements

• Bachelor's degree in an analytical or healthcare related field • 9+ years of relevant industry experience in clinical data management and analytics • 3+ years of using programming techniques to aggregate, extract, and analyze data across multi-table relational database schemas • Expert knowledge of Data Management processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management System • Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH • Understanding of ICH GCP as well as general knowledge of industry practices and standards • Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 • Advanced knowledge of MS Suite and Google document applications • In-depth understanding of clinical data management systems (e.g. Medrio, Rave) • Ability to compile, organize and analyze various types of data • Developing and adhering to SOPs that follow industry guidelines for effective and compliant data handling, archiving and modifying data management infrastructures • Excellent analytical and problem solving skills • Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy • Ability to effectively prioritize in a challenging, rapidly changing, and time sensitive environment with minimal guidance • Proven ability to learn new things continuously and quickly and navigating ambiguity • Ability to lead others work product either in line management or matrix reporting • Ability to work independently and as part of a multi-disciplinary team