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.
Own the data. Find the true story it's hiding.
What this role actually is- Investigation - you trace discordant results, outliers, and drift to their source and determine whether you're looking at real signal or a data artifact.
- Source-level verification - every critical field traced to origin; you're the one who finds the single transcription error in 10,000 rows.
- Reconciliation - lab results, sample inventory, demographics, and visit dates agree across systems, or you find out why.
- Telling it straight - you can stand in front of the science and regulatory team and explain what the data means, honestly - and hold the line when someone wants a prettier story than the data supports.
- Database lock - you're accountable for the dataset that goes to FDA, and you'll defend every value in it under audit.
- ALCOA+ / 21 CFR Part 11 - integrity isn't a checkbox here, it's the whole job.
How you'll work- Dig directly into raw data wherever it lives - EDC, exports, source documents - to get to the bottom of what it's saying.
- Build and refine eCRFs and edit checks that catch bad data at entry (Castor today; we're building our own EDC - you'll help shape the system that makes the truth easy to see).
- Set the standard for "clean" with our Philippines-based data team.
- Sit between clinical, lab, regulatory, and engineering - your dataset is the thing all of them trust.
Requirements- 3+ years clinical data management in a regulated environment (IVD/diagnostics a strong plus).
- 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.
- Bonus: FDA submission exposure (510(k), CLIA waiver); GCP/ICH familiarity.
What we're not looking for- Someone who reports the number without asking whether it's real.
- A "storyteller" who starts with the conclusion and back-fills the data to match.
- Extract, export, move on.
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
