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Regulatory operations specialist

Wakefield
Advanced Clinical
Operations specialist
Posted: 13 May
Offer description

Clinical Trial Transparency Anonymisation Specialist

Remote – UK

Permanent Position

FSP Opportunity through Advanced Clinical

Advanced Clinical is supporting a global biotech organisation in the search for a Clinical Trial Transparency Anonymisation Specialist to join their growing Clinical Operations / Trial Disclosure team.

This is an excellent opportunity for someone with experience in clinical trial disclosure, transparency, anonymisation, or regulatory document publishing who is looking to work within a highly collaborative global environment.


Key Responsibilities:


• Manage anonymisation of clinical trial documents and datasets for public disclosure

• Support EU CTR, ClinicalTrials.gov, EMA Policy 0070, and Health Canada PRCI submissions

• Develop anonymisation strategies and assess re-identification risk in line with GDPR guidance

• Collaborate with Biostatistics, Programming, Medical Writing, and Regulatory Operations teams

• Perform quality review of redacted/anonymised documents

• Support transparency and data-sharing initiatives globally


Requirements:


• Bachelor’s degree in a scientific or technical discipline

• Minimum 3 years’ experience within pharma, biotech, or CRO environments

• Experience with clinical trial transparency/disclosure activities

• Knowledge of EU CTR, EMA Policy 0070, ClinicalTrials.gov, or related regulations

• Understanding of anonymization/redaction methodologies and disclosure processes

• Strong communication and organisational skills

• Experience with document management systems and analytical tools


Fully remote role within the UK with minimal travel requirements.

#ClinicalResearch #ClinicalOperations #RegulatoryAffairs #ClinicalTrials #Transparency #Anonymization #EUCTR #RemoteJobs #BiotechJobs #PharmaJobs

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