Lead Data Manager
Tempus AI
full-time
Posted on:
Location Type: Remote
Location: Texas • United States
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- Responsible for all data management activities in support of 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 activities, including development and maintenance of the data management project file and close out activities, including locking and archival of the final project database
- Contribute to department process improvement efforts and authorship and/or review of department SOPs
Requirements
- Bachelor's degree in an analytical or healthcare related field
- 7+ years of relevant industry experience in clinical data management and analytics
- 3+ years of using programming techniques or software 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, Medidata 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
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementeCRF developmentdatabase developmentdata validationdata cleaningdata reportingdata transformationprogramming techniquesclinical data management systemsdata analysis
Soft Skills
analytical skillsproblem solvingorganizational skillsattention to detailprioritizationadaptabilityleadershipindependenceteam collaborationcommunication