Clinical Data Manager - Data Integrity & Investigation

RDI•Los Angeles, CA

2d•Remote

About The Position

This role focuses on data integrity and investigation within clinical trials for diagnostic tests. The Clinical Data Manager will be responsible for ensuring the accuracy and truthfulness of subject- and sample-level data across multiple concurrent studies. The core of the job involves investigating discrepancies, outliers, and data drift to identify root causes, whether they stem from the test, specimen, site, or data entry errors. This position requires a meticulous approach to data verification, reconciliation across different systems, and the ability to communicate findings honestly to scientific and regulatory teams. The role is critical for ensuring the dataset is accurate and defensible for regulatory submissions, such as to the FDA, and adheres to ALCOA+ principles and 21 CFR Part 11.

Requirements

3+ years of clinical data management experience in a regulated environment.
An investigative instinct; ability to chase anomalies to root cause and understand the 'why'.
Hands-on EDC experience (Castor, Cloudbyz, REDCap, Medidata, or similar).
Comfort working directly with raw data.
Proficiency in data integrity principles: SDV, query management, reconciliation, database lock, ALCOA+, Part 11.
Sufficient biostatistical literacy to differentiate real signal from artifact (concordance, outliers, method comparison).
Ability to communicate the true data story, even when it is not the preferred narrative.

Nice To Haves

Experience in IVD/diagnostics.
FDA submission exposure (510(k), CLIA waiver).
Familiarity with GCP/ICH guidelines.

Responsibilities

Investigate discordant results, outliers, and drift to determine their source and nature (real signal vs. data artifact).
Perform source-level verification, tracing critical fields to their origin to identify any transcription errors.
Reconcile lab results, sample inventory, demographics, and visit dates across different systems.
Communicate data findings honestly and accurately to science, regulatory, and other teams.
Ensure the integrity of datasets for regulatory submissions (e.g., FDA) and defend data values during audits.
Adhere to ALCOA+ principles and 21 CFR Part 11 requirements.
Work directly with raw data from various sources (EDC, exports, source documents).
Build and refine eCRFs and edit checks to capture data errors at the point of entry.
Help shape the development of the company's own EDC system.
Set data quality standards for the data team in the Philippines.
Collaborate with clinical, lab, regulatory, and engineering teams, ensuring the dataset is trusted by all.