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oura
Страна
США
Зарплата
127 500 $ – 178 000 $
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Clinical Data Manager

Оценка ИИ

Высокая оценка обусловлена сильным брендом компании, конкурентной заработной платой, наличием опционов и возможностью удаленной работы в инновационной сфере HealthTech.


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Сложность вакансии

ЛегкоСложно
Оценка ИИ

Роль требует редкого сочетания навыков: глубокого знания регуляторных стандартов клинических исследований (FDA, GCP) и технических навыков программирования на SQL/Python для автоматизации отчетности.

Анализ зарплаты

Медиана135 000 $
Рынок110 000 $ – 165 000 $
Оценка ИИ

Предлагаемая зарплата ($127k - $178k) находится на верхнем уровне рыночного диапазона для Clinical Data Manager в США, особенно учитывая бонус в виде акций (equity). Это отражает высокую потребность в специалистах с навыками программирования.

Сопроводительное письмо

I am writing to express my strong interest in the Clinical Data Manager position at Oura. With over three years of experience in clinical data management within the medical device and digital health sectors, I have developed a robust skill set that aligns perfectly with your Research Operations team's needs. My background includes hands-on experience with EDC systems like Medrio and REDCap, as well as a deep understanding of ICH-GCP and 21 CFR Part 11 regulations, ensuring that clinical study data remains compliant and inspection-ready.

What excites me most about this role is the opportunity to blend traditional clinical data management with modern technical skills. I am proficient in SQL and Python, which allows me to build automated data quality monitoring reports and real-time dashboards. Having worked in fast-paced environments, I am adept at managing CRO deliverables while maintaining sponsor oversight. I am eager to bring my expertise in CDISC standards and data validation to Oura to help scale your research operations and support the development of life-enhancing features for the Oura Ring.

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Откликнитесь в oura уже сейчас

Присоединяйтесь к Oura, чтобы внедрять инновации в сфере носимых устройств и управлять качеством данных, которые меняют жизни миллионов людей!

Описание вакансии

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.

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

We would love to have you on our team if you have:

  • 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.

What we offer:

  • 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.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI)

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to 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 (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Disclaimer: Beware of fake job offers!

We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:

  • 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.

Stay cautious and protect your personal details.

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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Навыки

  • SQL
  • Python
  • Clinical Data Management
  • ICH-GCP
  • FDA 21 CFR Part 11
  • HIPAA
  • EDC
  • Medrio
  • REDCap
  • CDISC
  • SDTM
  • ADaM
  • Tableau
  • Power BI

Возможные вопросы на собеседовании

Проверка технической грамотности в области автоматизации контроля качества данных.

Расскажите о вашем опыте использования Python или SQL для создания отчетов по качеству данных в клинических исследованиях. Какие метрики вы отслеживали?

Оценка понимания специфики медицинских девайсов и программного обеспечения как медицинского изделия.

С какими основными сложностями вы сталкивались при управлении данными в исследованиях SaMD (Software as a Medical Device) по сравнению с традиционными фармацевтическими КИ?

Проверка навыков управления внешними подрядчиками.

Опишите ваш подход к надзору за CRO (Contract Research Organization). Как вы обеспечиваете соблюдение стандартов качества данных при работе с внешними вендорами?

Оценка знаний регуляторных требований.

Как вы обеспечиваете соответствие процесса сбора данных требованиям 21 CFR Part 11 и HIPAA при интеграции данных с носимых устройств?

Проверка опыта работы со стандартами данных.

Каков ваш опыт работы со стандартами CDISC (SDTM/ADaM)? Как вы подходите к трансформации сырых данных из EDC в эти форматы?

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oura
Страна
США
Зарплата
127 500 $ – 178 000 $