[Hiring] Clinical Trial Transparency Anonymization Specialist @ICON plc

Role Description

As a Clinical Trial Transparency Associate at ICON, you will be responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The Anonymization Specialist will partner with internal and external collaborators on the planning, initiation, and delivery of anonymized documents and datasets in support of the EU Clinical Trial Regulation (EU CTR), ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, and data sharing.

• Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements.
• Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI.
• Work closely with Biostatistics and Programming groups and Medical Writing teams to identify and assimilate the required documents and datasets.
• Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance.
• Process datasets and documents and apply required transformations.
• Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA.
• Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications.
• Quality check of documents redacted/anonymized by other team members.
• Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System.
• Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents.

Qualifications

• Bachelor’s degree in a scientific or technical field.
• Minimum 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.).
• Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency.
• Demonstrated experience in global clinical trial disclosure and transparency processes and systems.
• Demonstrated Excel and analytical skills, working knowledge of SharePoint and/or document management systems.
• Strong communication, organizational, time management, and project management skills.
• Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie, ICMJE).

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.