Lead Data Manager

October 18

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Description

β€’ Passionate about precision medicine and advancing the healthcare industry? β€’ Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. β€’ 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. β€’ 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. β€’ Accountable for leading all data management activities for clinical studies, including: β€’ eCRF development β€’ Database build activities, including database development, edit check specifications and performance of user acceptance testing β€’ Data collection, data cleaning and reporting β€’ 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 β€’ Develop and execute data validation programs and generate queries on potentially discrepant data β€’ Design, develop and execute programs to support data reporting, central monitoring, identification of patients and data transformations. β€’ 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 β€’ Interface with internal functional teams responsible for data quality and delivery to ensure a robust, quality regulatory-grade data pipeline β€’ 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 β€’ Drive process improvement efforts and authorship and/or review of department SOPs

Requirements

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

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