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Manager of Clinical Trial Transparency

2 months ago

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

Position Title: Clinical Trial Transparency Manager

Location: Remote

Key Responsibilities:

  • Guide the Transparency team on the complete Clinical Trial process and execution of trials.
  • Conduct necessary clinical trial registration and results disclosure activities.
  • Evaluate the workflow between Clinical Management and the Clinical Trial Transparency & Disclosure team, recommending enhancements as required.
  • Work alongside the system implementation team to conduct User Acceptance Testing (UAT) on transparency platforms, ensuring effective operations and suggesting improvements.
  • Create training programs for the Clinical Trial Transparency & Disclosure team on the use of new systems.
  • Review documents for redaction and provide essential insights regarding the applicability of redactions for product registration.
  • Keep abreast of transparency and disclosure regulations, guidelines, and industry standards.
  • Offer proactive transparency-related advice and information to cross-functional teams for global submissions or disclosures.

Essential Qualifications:

  • At least 5 years of experience in the pharmaceutical or biotechnology sector.
  • Practical experience in Clinical Trial management.
  • Thorough understanding of transparency regulations, including FDAAA 801, EU CTR 536/2014, and Health Canada Public Release of Clinical Information.
  • Experience in clinical transparency, including the redaction of clinical documents for public disclosure, with a solid grasp of requirements for redacting commercially confidential information and personal protected data.
  • Experience in managing vendors and collaborating with multiple Contract Research Organizations on behalf of the sponsor.
  • Demonstrated ability to manage and deliver projects with tight deadlines effectively.
  • Familiarity with automated platforms for Clinical Trial Transparency.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Pro, and SharePoint.
  • Knowledge of disclosure strategies, best practices, and lean authoring is a plus.