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Clinical Database Associate

Senseonics, Inc.

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GERMANTOWN, MD
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Job Description

As posted by the hiring company

Job Overview:

Job Summary:

The Clinical Database Associate is responsible for the review of the clinical study data which is stored within an Electronic Data Capture (EDC) system. Data will be reviewed to ensure it is consistent, complete, and accurate. Prepare data for data analysis and reporting. 

Duties and Responsibilities include, but are not limited to:

  • Assist with creating and validation of electronic case report forms and edit checks for studies
  • Review site data entry and generate manual queries to ensure accuracy, completeness, and consistency
  • Provide reports on timeliness of site’s data entry, missing data and outstanding queries
  • Collaboration with appropriate team members to resolve data issues
  • Maintain organized, complete, and up-to-date documentation 
  • Track outstanding issues and following-up until resolution
  • Contact with providers (internal and external) for supplies needed for conducting clinical trials
  • Material preparation for clinical studies and the shipment of those materials
  • Maintain traceability logs for Investigational Product used in clinical studies
  • Handles confidential material relevant to clinical trials
  • Develop/use systems for organizing data to analyze, identify and report trends. 
  • Prepare data reports, tables and graphs for regulatory submissions, IRB submissions, presentations and publications
  • Ensure the plan for data management is properly executed by Understanding the requirements for study implementation and data collection
  • Report any database bugs or needed enhancements to clinical database designer

Knowledge, Skills, Abilities and Requirements:

  • Bachelor’s degree in Computer Science, Engineering, Life Sciences or related field preferred, or equivalent life experience 
  • 1-2 years of clinical/data management experience within the pharmaceutical, biotech or CRO industry
  • Knowledge of clinical data, and ICH Good Clinical Practices, 21 CFR part 11 and other regulatory requirements.
  • Basic skills in applicable computer programs, MS Office
  • Knowledge/experience with Excel and Matlab a plus 
  • Experience with EDC system by IBM Clinical Development is a plus but will train qualified candidates
  • Strong verbal and written skills, good organization, interpersonal and team skills 
  • Excellent attention to detail
  • Ability to work independent in a group setting
  • Ability to adjust to changing priorities