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ŌURA

Better lives through better sleep.

Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteSeniorTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

75 days ago

Salary

$151.3K - $178K / year

Seniority

Senior

Bachelor Degree3 yrs expEnglishGCPPythonSQL

Job Description

Clinical Data Manager

ŌURA

• 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

Job 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

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