Develop and maintain data quality monitoring frameworks, including defining key data quality metrics and thresholds
Build and maintain quality dashboards and reports using programming languages (e.g., SQL, Python) and BI tools to provide near real-time study insights
Oversee data validation, coding, reconciliation (e.g., safety, device, external vendor data), and risk-based review processes
Ensure compliance with ICH-GCP, 21 CFR Part 11, HIPAA, and applicable FDA expectations for regulated SaMD trials
Partner with Engineering and Data teams to support ingestion, transformation, and traceability of multi-source clinical datasets (e.g., wearable data, ePRO, device integrations, CRO exports)
Manage CRO and vendor data management deliverables, ensuring sponsor oversight and quality standards are met
Identify data-related risks early and drive mitigation strategies
Contribute to SOP development and help standardize scalable, repeatable data management practices across Research Operations

Requirements

3+ years of industry experience in clinical data management within medical device, digital health (SaMD), biotech, or CRO environments
Experience supporting regulated clinical trials and regulatory submissions (e.g., 510(k), De Novo, CE/MDR)
Hands-on experience with industry-standard EDC systems (e.g., Medrio, REDCap, Rave, TrialKit)
Strong working knowledge of ICH-GCP, 21 CFR Part 11, and data privacy regulations
Experience managing database builds, edit checks, UAT, query resolution, and database lock activities
Proficiency in SQL and/or Python, with demonstrated experience building data quality reports, dashboards, and validation queries
Experience working with structured clinical datasets and familiarity with CDISC standards (SDTM/ADaM) preferred
Experience collaborating cross-functionally with Clinical Operations, Biostatistics, Regulatory, Engineering, and CRO partners
Comfort operating in a fast-paced, product-driven environment with multiple concurrent studies
Flexibility with scheduling to support global collaborators when needed.

Benefits

Competitive salary and equity packages
Health, dental, vision insurance, and mental health resources
An Oura Ring of your own plus employee discounts for friends & family
20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
Paid sick leave and parental leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SQLPythondata quality metricsdata validationcodingreconciliationdata managementdatabase buildsedit checksquery resolution

Soft Skills

collaborationrisk managementproblem-solvingflexibilitycommunicationorganizational skillsattention to detailleadershipadaptabilitytime management