Clinical Data Specialist jobs in United States
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Flatiron Health · 3 weeks ago

Clinical Data Specialist

Flatiron Health is dedicated to reimagining the infrastructure of cancer care. They are seeking a Clinical Data Specialist to interpret and organize clinical oncology data, manage real-world data deliverables, and contribute to data quality and process improvements.

BiotechnologyCloud ComputingElectronic Health Record (EHR)Health CareHealth DiagnosticsHospitalPersonal Health
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Work & Life Balance
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H1B Sponsor Likelynote

Responsibilities

Manage, maintain, and serve as clinical data expert for a portfolio of real-world data deliverables
Plan and execute real-world data management activities through the lifecycle of a product, including data model development, data processing methods (e.g., abstraction, structured, machine learning, etc.), design of data capture forms and associated instructions, creation of quality check logic, analysis of controls for efficiency and effectiveness, and development of quality check resolution guidance
Surface opportunities for product enhancements by leveraging feedback channels, including but not limited to client requests, clinical landscape developments, industry trends, regulations, and/or data processing challenges
Plan and execute feasibility experiments for variable development, applying insights to align and recommend optimal variable design, data source(s), efficiency, quality, and production cost
Contribute to the development and maintenance of internal and external real-world data variable user guidance
Identify opportunities for improvement in processes/workflows, contribute to problem-solving discussions with stakeholders, and support the design and implementation of solutions, including but not limited to tooling, templates, or modifications to software platforms
Maintain audit-readiness of documentation through conformance to procedures and applicable data standards

Qualification

Clinical data managementData extraction languageClinical research knowledgeData analysis platformsStatistical knowledgeProject managementCommunication skillsProblem-solvingOrganizational skills

Required

2+ years of experience working in clinical data management, clinical or lab research, and/or related work experience in a medical device or pharmaceutical industry/company
Experience navigating clinical databases such as EDCs, EMRs, or other data management systems
Familiarity with clinical research and medical product development, clinical trial processes and related regulatory requirements or information governance frameworks (e.g. ICH GCP, Good Clinical Data Management Practices, 21CFR11, HIPAA)
Awareness of pharmaceutical industry health data standards such as CDISC and MedDRA
Strong project management, organizational, analytical, and written and verbal communication skills
Self-motivator who is able to identify problems and propose solutions in a highly dynamic and fast-paced environment
Bachelor's or Master's degree in science or healthcare related field, or equivalent practical experience
Experience with data extraction language (e.g., SQL, SAS, R, Python, etc.) and/or data analysis platforms (e.g., PowerBI, SPSS, Tableau)
Foundational knowledge of statistics and experimental design
Manage, maintain, and serve as clinical data expert for a portfolio of real-world data deliverables
Plan and execute real-world data management activities through the lifecycle of a product, including data model development, data processing methods (e.g., abstraction, structured, machine learning, etc.), design of data capture forms and associated instructions, creation of quality check logic, analysis of controls for efficiency and effectiveness, and development of quality check resolution guidance
Surface opportunities for product enhancements by leveraging feedback channels, including but not limited to client requests, clinical landscape developments, industry trends, regulations, and/or data processing challenges
Plan and execute feasibility experiments for variable development, applying insights to align and recommend optimal variable design, data source(s), efficiency, quality, and production cost
Contribute to the development and maintenance of internal and external real-world data variable user guidance
Identify opportunities for improvement in processes/workflows, contribute to problem-solving discussions with stakeholders, and support the design and implementation of solutions, including but not limited to tooling, templates, or modifications to software platforms
Maintain audit-readiness of documentation through conformance to procedures and applicable data standards

Preferred

You are familiar with all aspects of how cancer is treated, from diagnosis to recovery, and are fluent in cancer terminology
You have experience managing data for real-world evidence programs, registries, or other post-marketing studies
You are familiar with machine learning model development
You have an advanced degree in biomedical science, informatics, biostatistics, or relevant experience

Company

Flatiron Health

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Flatiron Health is a healthcare technology company that aims to improve lives by learning from the experience of every cancer patient.

H1B Sponsorship

Flatiron Health 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
2025 (17)
2024 (28)
2023 (16)
2022 (27)
2021 (29)
2020 (33)

Funding

Current Stage
Late Stage
Total Funding
$324.95M
Key Investors
RocheGoogle Ventures
2021-12-23Series D· $11.95M
2018-02-15Acquired
2016-01-06Series C· $175M

Leadership Team

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Bruce Gottlieb
Chief Operating Officer
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Stephanie Reisinger
Senior Vice President and General Manager, Real-World Evidence (RWE)
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Company data provided by crunchbase