Clinical Data Manager

We are looking for a Clinical Data Manager to join our Research Operations team, which drives the end-to-end execution of studies that drive new feature development and validation.  

In this role, you will be part of the full lifecycle of clinical study data — from database build and validation through database lock and archival — ensuring that data is compliant, traceable, and inspection-ready. You will also take a hands-on role in building data quality monitoring reports and dashboards using programming languages and analytics tools to provide real-time visibility into study health.

You’ll work closely with Clinical Operations, Regulatory, Biostatistics, Science, Data Engineering, and external vendors to ensure that our data management practices meet FDA, ICH-GCP, and internal quality standards while enabling speed and scalability.

This is a remote US role with a preference for candidates based on the East coast.

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations.

• →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

• 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