Data Transparency Specialist – Data Sharing, Anonymisation and Clinical Trial Disclosure (f/m/d - part/full-time)
Core
Assessing data sharing requests, redacting clinical trial documents, anonymizing patient data, and disclosing trial information to regulatory agencies.
Role type
Data Transparency Specialist (Clinical Trials)
Builds
Redaction Proposal Document Packages (RPDP) and clinical trial disclosure submissions for EMA and Health Canada
Domain
Life sciences / Clinical trials / Regulatory compliance
Required skills
Data anonymization, Clinical trial document redaction, Regulatory compliance (EMA/Health Canada), Study record maintenance, Timeline management, International team coordination
Preferred skills
R/SAS programming, Medical writing, Clinicaltrials.gov/EudraCT/CTIS experience, CRO/pharma background
Technologies
R, SAS, Clinicaltrials.gov, EudraCT, CTIS
Responsibilities
Review informed consent forms for data sharing feasibility, Prepare RPDP for regulatory submission, Manage timelines for international law compliance, Coordinate with international study teams
Seniority
Mid-level, hands-on IC
