Analyst, Clinical Trial Transparency, Anonymization
Core
Process clinical study documents for anonymization and pseudo-anonymization to support regulatory disclosure and data sharing.
Role type
Individual contributor clinical data anonymization specialist
Builds
Submission-ready anonymized clinical documents and reports for regulatory teams
Domain
Clinical trials, regulatory compliance, data privacy
Required skills
Clinical study datasets knowledge, Clinical Study Reports (CSR) structure, SAS programming, System User Acceptance Testing (UAT), Data risk management, ICH E3 standards, Database set-up, Report publishing requirements
Preferred skills
Medical writing experience, SDTM/ADaM datasets, Validated systems delivery, Statistical programming languages, Global Medicines Development knowledge
Technologies
SAS, Clinical Trial Transparency tools
Responsibilities
Create anonymized clinical documents following SOPs, Contribute to Anonymization Reports, Perform System UAT, Work with Biometrics Data Operations on risk quantification, Ensure adherence to data privacy policies, Quality check delivered work, Support Clinical Trial Transparency activities
Seniority
Individual contributor, task-focused