Job Title: Clinical Trial Transparency Consultant
Work Location: Remote, Princeton, NJ
Essential Duties and Responsibilities:
- Perform required clinical trial registration and/or results disclosure activities as necessary.
- Assess the process between Clinical Management and the CTT&D team, suggesting improvements where needed.
- Collaborate with the system implementation team to perform User Acceptance Testing (UAT) on transparency platforms like Prime, ensuring smooth processes and recommending enhancements.
- Develop training sessions for the CTT&D team on utilizing new platforms.
- Evaluate documents for redaction and provide critical insights on the applicability of redactions for product registration.
- Stay updated on transparency and disclosure regulations, guidelines, and industry standards.
- Proactively provide transparency-related guidance and information to cross-functional teams for global submissions or disclosures.
Required Competencies:
- Minimum 2-3 years of experience in the pharma/biotech industry.
- Hands-on experience in Clinical Trial management.
- Comprehensive knowledge of transparency regulations, including FDAAA 801, EU CTR 536/2014, and Health Canada (HC) Public Release of Clinical Information (PRCI).
- Experience in clinical Transparency, including redacting clinical documents for public disclosure, with a strong understanding of requirements for redacting commercially confidential information (CCI) and personal protected data (PPD).
- Experience in vendor management and working with multiple Contract Research Organizations (CROs) on behalf of the sponsor.
- Experience with automated platforms for Clinical Trial Transparency.
- Proficiency in Microsoft Office suite (Word, Excel, PowerPoint), Adobe Pro, and SharePoint.
- Familiarity with disclosure strategy, best practices, and lean authoring is advantageous.
