Role Overview:
We are seeking a detail-oriented and tech-savvy Clinical Data Specialist to lead the extraction, organization, and structuring of clinical research data to support future AI and machine learning initiatives. This role bridges clinical operations and data science, ensuring that data from past and ongoing trials is clean, standardized, and AI-ready.
Key Responsibilities:
Extract structured and unstructured data from clinical trials, staff emails, staff computers, EDC systems, CRFs, and related sources
Standardize and organize data across formats and trials for consistency and interoperability
Implement data schemas that support downstream AI/ML analytics and predictive modeling
Collaborate with clinical, regulatory, and IT teams to map, validate, and maintain data pipelines
Work with data science teams to define annotation, labeling, and metadata requirements
Ensure data compliance with GCP, HIPAA, GDPR, and relevant regulatory standards
Develop documentation, data dictionaries, and data management protocols for reusability
Manage storage solutions (e.g., cloud or local) for scalable and secure data access
Perform basic data quality checks, wrangling, and enrichment where needed
Required Qualifications:
Bachelor’s or Master’s degree in Health Informatics, Computer Science, Life Sciences, or a related field
3+ years of experience in clinical data management, clinical research, or health informatics
Familiarity with EDC systems (e.g., Medidata, REDCap, Veevavault, etc)
Proficiency in working with clinical trial protocols, data tables, and adverse event logs
Experience with data tools such as SQL, Python, or R for data extraction and cleaning
Understanding of AI/ML data requirements and clinical data annotation best practices
Strong attention to detail and ability to handle sensitive health data securely
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