Data Transparency Specialist – Data Sharing, Anonymisation and Clinical Trial Disclosure (f/m/d - part/full-time)

Your responsibilities will include

• Assessing data sharing requests, reviewing informed consent forms for data sharing feasibility
• Redaction of clinical trial documents and anonymisation of individual patient data
• Preparing Redaction Proposal Document Packages (RPDP) for submission to EMA and Health Canada in compliance with EMA Policy 0070 and Health Canada PRCI 
• Disclosure of clinical trial information for drugs and medical devices: Registering protocols and preparing results for submission to local and global regulatory agencies
• Maintenance of study records including status tracking and administrative aspects 
• Managing timelines for timely submission to ensure compliance with international laws, regulations, and guidelines
• Communicate and coordinate with international study teams, act as a central point of contact

Your profile

• University degree in data science or life science related discipline
• Knowledge of drug development and clinical science
• Experience in redaction of CCI and PPD in clinical documents is a plus
• Knowledge of EMA policy 0070 and Health Canada PRCI is a plus
• Experience in data anonymization and programming (e.g., R/SAS) is a plus
• Knowledge of the clinical trials disclosure regulatory environment and experience with Clinicaltrials.gov and EudraCT/CTIS is a plus
• Experience in m