Lead Data Manager

Tempus AI · Vertical AI · TX · Remote

This role is for a Lead Data Manager in precision medicine, focusing on clinical evidence studies for cancer patients. Responsibilities include all data management activities such as eCRF development, database build, data collection, cleaning, validation, reporting, and ensuring data quality and regulatory compliance. The role requires extensive experience in clinical data management, analytics, database programming, and knowledge of healthcare regulations like CDISC, ICH GCP, and 21 CFR Part 11.

What you'd actually do

  1. 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
  2. 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
  3. Develop and execute data validation programs and generate queries on potentially discrepant data
  4. Design, develop and execute programs to support data reporting, central monitoring, identification of patients and data transformations.
  5. 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

Skills

Required

  • 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

Nice to have

  • Bachelor’s degree in pharma science, research methodology, computer science, computer engineering, or data science
  • Experience working with EMRs such as EPIC
  • Experience working with Google Looker and dbt
  • Oncology experience (Breast Cancer, Lung cancer, Hematologic Cancers etc.)

What the JD emphasized

  • 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