Clinical Data Manager - Data Integrity & Investigation

Investigation

You trace discordant results, outliers, and drift to their source and determine whether you're looking at real signal or a data artifact.

Subject- and Sample-Level Data 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)
• Sit between clinical, lab, regulatory, and engineering — your dataset is the thing all of them trust

About RDI

RDI Trials is building a different kind of CRO. We are an IVD-focused contract research organization. Since 2008 we've run 300+ diagnostic trials for the largest test makers in the world. This is not a traditional, process-heavy environment. We are a small team that moves fast and expects people to take real ownership. There's no passing things along or waiting for direction. If something needs to get done, you step in and figure it out. The pace is high. The expectations are high. But for the right person, it's a place where you can learn quickly and have real impact.

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 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
Subject- and sample-level data 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

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)