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Clinical Trial Transparency

2 months ago

Princeton, United States SYSTEM EDGE (USA) L.L.C. Full time

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.