Purpose:
This function supports the protection of patient privacy when clinical trial data is shared externally.
Typical use cases:
- Regulatory submissions
- Data sharing with researchers
- Health authority requests
- External collaborations
- Clinical trial transparency initiatives
Typical responsibilities:
- Review datasets for personally identifiable information (PII).
- Apply anonymization methodologies.
- Remove or mask sensitive variables.
- Assess re-identification risk.
- Create anonymized SDTM and ADaM datasets.
- Produce anonymization reports and documentation.
- Validate anonymized outputs.
Key technical skills:
- SAS programming.
- SDTM and ADaM expertise.
- Clinical trial disclosure processes.
- Metadata and standards expertise.
- Knowledge of data privacy regulations:
- GDPR
- HIPAA
- EMA Policy 0070
Ideal profile:
- Clinical programming teams.
- Regulatory programming.
- Clinical disclosure teams.
- Data transparency functions.
- 4+ Years of relevant experience
Success factors:
- Meticulous attention to detail
- Strong compliance mindset
- Understanding of patient privacy regulations
- Process-oriented approach
- Ability to work within heavily governed environments
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