Clinical Data Manager

2 days ago

Carlsbad, United States Yoh Full time
Job Title: Clinical Data Manager

Yoh, a leading staffing firm, is seeking a highly skilled Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for overseeing the management of clinical trial data, specifically related to In Vitro Diagnostics (IVD) studies. Your primary focus will be on ensuring data accuracy, compliance, and quality, while working closely with cross-functional teams to achieve project goals.

Key Responsibilities:
  • Develop and implement comprehensive Data Management Plans (DMPs) tailored to the unique needs of IVD studies.
  • Collaborate with project teams to define database specifications, including eCRF design and database setup in the context of IVD trials.
  • Ensure 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, with a focus on the integrity and traceability of diagnostic data.
  • 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.
  • Monitor data entry progress and ensure timely completion, leveraging EDC reporting tools.
  • Generate and review data listings, summaries, and reports, and assist in the preparation of data for statistical analysis.
  • Provide support for interim and final database locks, ensuring that diagnostic data is fully validated and ready for analysis.
  • Ensure all data management documentation is accurate, complete, and compliant with SOPs, clients, and regulatory requirements.
  • Work closely with biostatistics, clinical operations, regulatory, and IT teams to ensure seamless data management processes tailored to IVD trials.
  • Act as the primary point of contact for data management activities with external vendors and stakeholders.
  • Train clinical site staff on data management procedures, software, and specifically on Veeva Vault CDMS, with a focus on the nuances of IVD data.
  • Provide ongoing support and troubleshooting for data-related issues, particularly those related to the management of diagnostic data.
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.
  • Technical skills: 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.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

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