What are the responsibilities and job description for the Lead Data Manager position at Tempus?
Passionate about precision medicine and advancing the healthcare industry?
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.
What You’ll Do
- 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
Required Knowledge And Skills
- Bachelor’s degree in an analytical or healthcare related field
- 9 years of relevant industry experience in clinical data management and analytics
- 5 years of experience in Oncology trials (experience in Hematologic Oncology preferred)
- 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
Nice To Haves
- Bachelor’s degree in computer science, computer engineering, or data science
- Advanced degree in Healthcare informatics or clinical research
- Experience with Real-World Evidence (RWE) observational trials is a plus
- Experience working with EMRs such as EPIC
- Experience working with Google Looker and dbt
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