Clinical Data Manager - Data Integrity & Investigation
On-site · Van Nuys, California, United States
Job Summary
Own subject- and sample-level data across 20–30 concurrent method-comparison and specimen-collection studies — and ensure the dataset tells the truth. Investigate discordant results, trace data artifacts to source, and verify every critical field to origin. Build and refine eCRFs and edit checks, set data-clean standards with the Philippines-based data team, and liaise between clinical, lab, regulatory, and engineering to deliver an auditable, FDA-ready dataset. Communicate findings to the science and regulatory teams and defend data values during database locks under ALCOA+ / 21 CFR Part 11.
Required Qualifications
- 3+ years clinical data management in a regulated environment (IVD/diagnostics a strong plus)
- Hands-on EDC experience (Castor, Cloudbyz, REDCap, Medidata, or similar) and comfort working directly with raw data
- SDV, query management, reconciliation, database lock, ALCOA+, Part 11
- Biostatistical literacy to tell real signal from artifact
- Ability to explain data to science/regulatory teams and defend data integrity during audits
- FDA submission exposure (510(k), CLIA) and GCP/ICH familiarity (Bonus)
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