Clinical Trial Transparency Specialist

Job title: Clinical Trial Transparency Specialist

About the Role As a Clinical Trial Transparency Specialist at ICON, you will be responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The role partners with internal and external collaborators to plan, initiate, and deliver anonymized documents and datasets in support of EU CTR, ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions.

What You'll Do

• 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, Programming, and Medical Writing to identify and assimilate 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 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.

What We're Looking For

• 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).

Compensation & Benefits Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you. You are trained on data up to October 2023.