Clinical Data Quality Lead jobs in United States
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PicnicHealth · 6 hours ago

Clinical Data Quality Lead

PicnicHealth is revolutionizing non-interventional clinical research through AI, aiming to simplify clinical trials and enhance patient engagement. The Clinical Data Quality Lead will oversee data integrity and quality across various studies, managing a team while collaborating with product teams to operationalize new data capabilities.

AnalyticsBig DataBiotechnologyData VisualizationHealth CareMedical
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H1B Sponsor Likelynote
Hiring Manager
Jeanne Sanchez, PHR
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Responsibilities

Lead & Scale the Team: Lead, mentor, and scale a team of Clinical Data Quality Managers. You will foster a culture of high performance and decisive action, and evolve the function to support the requirements of a rapidly growing study portfolio
Define the Operational Quality Framework: Define and implement the overarching quality standards and operational processes to support our study portfolio. You will build scalable workflows across risk-based monitoring, escalation management, and critical data collection materials (e.g., CRFs, CRF guidelines, eClinRO scripts, abstractor training, etc.)
Operationalize Diverse Data Sources: You are excited by the complexity of integrating non-EHR data sources like wearables, PROs, and virtual ClinROs. You will build the operational scaffolding for new data sources —whether that means drafting assessment scripts, hiring subject matter experts, or defining what 'high quality' looks like for a novel data type
Drive Decision-Making in Ambiguity: Serve as the primary operational decision-maker for complex data quality considerations. When clinical guidelines are gray or source data is messy, you will make the calls required to keep studies moving, maintaining scientific rigor
Oversee Quality Across the Portfolio: Own the execution of quality monitoring across all studies. You will direct your team to analyze trends not just to fix errors, but to identify systemic root causes and implement portfolio-wide improvements
Operationalize Product & AI Capabilities: Partner with Product to roll out new data capabilities and workflows to your team. You will also set an example for the team by actively experimenting with and refining our AI capabilities, ensuring that as our technology evolves, it remains practical and seamlessly integrated into daily operations
Cultivate Cross-functional Relationships: Facilitate strong partnerships with Epidemiology, Biostatistics, Product, Commercial, Recruitment, and Project Management teams. You will ensure that clinical data feasibility and quality insights are considered early during study design to mitigate risks to study success

Qualification

Clinical data managementData quality monitoringPeople managementAI integrationData abstractionOperational process designCommunication skillsBuilder mindsetTech fluencyCross-functional collaboration

Required

7+ years of 'in the weeds' experience. Proven background in clinical/real-world data, data management, and data quality, particularly in support of observational research studies
Deep familiarity with data abstraction from medical records, designing CRFs/completion guidelines, and developing and implementing quality monitoring plans
A bachelor's degree in a life science, health, or clinical field
5+ years of people management experience, ideally in a high-growth or startup environment
A builder mindset, with a track record of building processes where none existed
Comfortable making decisions with incomplete information, and love bringing order to chaos
Tech and data fluency. Excited about the potential of AI in research and healthcare
Comfortable collaborating with Product Managers and Engineers
You are comfortable managing multiple concurrent research projects across diverse therapeutic areas
Excellent communication skills and a demonstrated ability to collaborate across teams
Ability to communicate complex clinical and scientific concepts to non-clinicians and non-scientists

Preferred

A clinical degree (e.g., RN, NP, PA, DNP, etc.) is a value-add, but not required
Past experience integrating and operationalizing workflows across diverse data sources (e.g., wearables, ePROs, eClinROs) is a huge plus

Benefits

Comprehensive benefits including above market Health, Dental, Vision
Family friendly environment
Flexible time off
401k plan
Free PicnicHealth account
Equipment and internet funds for home office set up
Wellness Stipend

Company

PicnicHealth

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PicnicHealth helps patients easily access their medical records and gives them the opportunity to contribute data to medical research.

H1B Sponsorship

PicnicHealth has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (2)
2021 (3)
2020 (2)

Funding

Current Stage
Growth Stage
Total Funding
$97M
Key Investors
B CapitalFelicisAmplify Partners
2022-06-27Series C· $60M
2020-09-01Series B· $25M
2018-01-01Series A· $10M

Leadership Team

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Noga Leviner
Co-Founder & CEO
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Troy Astorino
Co-Founder and CTO
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Company data provided by crunchbase