Clinical Data Manager

20 hours ago

Carlsbad, United States DCN Diagnostics Full time
Job Summary

We are seeking a highly skilled Clinical Data Manager to join our team at DCN Diagnostics. As a Clinical Data Manager, you will be responsible for the oversight and management of clinical trial data, ensuring accuracy and compliance with regulatory standards.

Key Responsibilities
  • Develop and implement comprehensive Data Management Plans (DMPs) tailored to the unique needs of IVD studies.
  • Collaborate with the project team to define database specifications, including eCRF design and database setup in the context of IVD trials, using Veeva Vault CDMS.
  • Ensure that data collection methods are optimized for the specific requirements of IVD clinical trials, such as handling large volumes of assay data and ensuring traceability of diagnostic results.
  • Oversee the setup, testing, and maintenance of clinical trial databases, ensuring they are configured to handle complex IVD data structures.
  • Ensure databases are compliant with IVD-specific regulatory requirements (e.g., FDA 21 CFR Part 820, IVDR, CLIA).
  • Coordinate data entry, data cleaning, and validation processes for IVD trials, ensuring that diagnostic data, including test results, sample data, and calibration details, are accurately captured and verified.
  • Perform quality checks and resolve data discrepancies, with particular attention to the technical validity of diagnostic data and its correlation with clinical outcomes.
  • Generate and review data listings, summaries, and reports.
  • Assist in the preparation of data for statistical analysis, ensuring that all diagnostic data is appropriately formatted for regulatory submissions.
Requirements
  • Bachelor's degree in life sciences, medical technology, bioinformatics, computer science, or a related field. Advanced degree preferred.
  • Minimum of 3-5 years of experience in clinical data management, with a strong preference for experience in the IVD or medical device industry.
  • Experience working in a CRO environment with a focus on IVD studies is highly desirable.
  • Proficiency in clinical data management systems (e.g., Medidata, Oracle Clinical, REDCap) with specific experience in Veeva Vault CDMS is preferred.
  • Strong understanding of regulatory requirements specific to IVD products (e.g., FDA 21 CFR Part 820, IVDR, CLIA).
  • Familiarity with programming languages (e.g., SAS, SQL) is a plus.
Why Join Us

Be part of a cutting-edge biotech company that is making a real impact in life sciences. Collaborate with leading scientists and professionals in the field. Competitive salary, benefits, and career advancement opportunities. A fast-paced and innovative environment with a focus on growth and development.

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