Clinical Data Manager
ŌURA
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
À propos
Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office.
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.
What You’ll Do
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
Qualifications
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 At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.
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
Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates\' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.
Region 1 $151,300 - $178,000
Region 2 $138,550 - $163,000
Region 3 $127,500 - $150,000
A recruiter can determine your zones/tiers based on your US location.
EEO and Safety Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. We will not tolerate discrimination or harassment based on age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will provide reasonable accommodations to participate in the interview process and to perform essential job functions as needed.
Disclaimer: Beware of fake job offers. We\'ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Our jobs are listed only on the ŌURA Careers page and trusted job boards. We will never ask for personal information like ID or payment for equipment upfront. Official offers are sent through Docusign after a verbal offer, not via text or email.
To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization\'s location. Oura is not responsible for any fees related to unsolicited resumes.
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Compétences linguistiques
- English
Avis aux utilisateurs
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