Employment Type: Permanent Position

Job Category: Clinical Research / Data Management

Department: Clinical Operations

Reports To (Position): Director of Clinical Operations

Job Number: 3330488

Position Overview

We are seeking a Clinical Data Manager who brings more than just technical expertise — someone who understands the story behind the data and how it impacts regulatory decisions, patient outcomes, and trial success. This role bridges clinical operations and biostatistics, owning the full lifecycle of subject- and sample-level data across diagnostic clinical trials.

This is a high-impact opportunity for a data-driven professional who thrives in a fast-paced, collaborative environment and wants their work to directly influence FDA submissions and strategic decisions.

Responsibilities

• Build and optimize electronic case report forms (eCRFs) to streamline physician data entry and reduce protocol deviations
• Review, clean, and validate large clinical datasets (e.g., subject metadata, lab results, demographics)
• Identify and flag inconsistencies, errors, and outliers with precision and context
• Format data for downstream analysis, including standardization, categorical formatting, and logic checks
• Support basic statistical reporting (e.g., inclusion criteria tracking, diversity metrics, ROC curves)
• Collaborate with regulatory and scientific teams to ensure datasets support submission claims
• Partner with Salesforce developers and EDC platforms to enhance usability of paperless trial systems
• Create real-time reports to track site enrollment, sample quality, and trial performance

Qualifications / Skills

• 3+ years of experience in clinical data management or diagnostics data analysis
• Strong Excel skills and familiarity with EDC platforms (e.g., Castor, Cloudbyz, REDCap)
• Exposure to biostatistics concepts such as sensitivity/specificity, AUC, stratification
• Ability to write queries, troubleshoot messy data, and clearly explain logic to both technical and scientific teams
• Strong attention to structure, logic, and accuracy — a mindset that questions data before trusting it
• Bonus: Experience with R, SAS, or Python for data QA or analysis
• Even better: Experience supporting FDA submissions or working in regulated diagnostics

Work Environment & Additional Information

• Work Schedule: Full-time; standard business hours with flexibility for project needs
• Travel: Minimal, but may include occasional travel for team meetings or site visits
• Safety: Adherence to all company safety policies and procedures is required
• Quality Responsibility: Ensure data integrity and compliance with GCP and internal quality systems

Equal Opportunity & Accessibility

The physical demands and work environment described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions in accordance with the Americans with Disabilities Act.

This job description is intended to provide an overview of the responsibilities and requirements for this position. It is not an exhaustive list, and additional duties may be assigned as needed.