Clinical Trial Transparency Anonymization Specialist
Core
Processing anonymization of clinical trial documents and datasets for public disclosure to regulatory authorities and publications.
Role type
Clinical Trial Transparency Anonymization Specialist
Builds
Anonymized clinical trial documents and datasets for EU CTR, ClinicalTrials.gov, and regulatory submissions
Domain
Healthcare / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Anonymization planning, Direct and indirect identifier identification, Re-identification risk assessment, GDPR compliance, Clinical trial disclosure processes, Regulatory guidelines knowledge, Document transformation, Quality assurance, Excel, SharePoint
Preferred skills
Biostatistics collaboration, Medical writing collaboration, Regulatory operations collaboration, Technology tools for document delivery
Technologies
SharePoint, Document management systems
Responsibilities
Manage and facilitate anonymization of datasets and documents against planned timelines, Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI, Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk, Process datasets and documents and apply required transformations, Quality check of documents redacted/anonymized by other team members
Seniority
Mid-level, hands-on IC
