Clinical Data Manager - Data Integrity & Investigation
Van Nuys, United States On-site
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About the role
When a new assay disagrees with the predicate, somebody has to figure out why . Is it the test? The specimen? The site? A single keystroke at data entry? Most "data people" report the discordance and move on. We're looking for the one who treats it as a case to crack. You'll own subject- and sample-level data across 20–30 concurrent method-comparison and specimen-collection studies — and your real job is to make sure the dataset tells the truth. Not the convenient version. Not the version that makes a result look cleaner than it is. What actually happened. You check every cell because the truth lives in the cells, and you chase every anomaly to root cause because "looks off" is where the work starts .
What you'll bring
- An investigative instinct — you chase anomalies to root cause and aren't satisfied until you know why, not just what.
- Hands-on EDC experience (Castor, Cloudbyz, REDCap, Medidata, or similar) and comfort working directly with raw data — we care that you get to the bottom of it, not which tool you reach for.
- Command of the integrity discipline: SDV, query management, reconciliation, database lock, ALCOA+, Part 11.
- Enough biostatistical literacy to tell real signal from artifact (concordance, outliers, method comparison) — without torturing the data to fit a conclusion.
- The spine to tell the true story even when it's not the one people want to hear.
- GCP/ICH familiarity.
- 3+ years clinical data management in a regulated environment (IVD/diagnostics a strong plus).
- Bonus: FDA submission exposure (510(k), CLIA waiver)