Senior Manager, Clinical Trial Disclosure

3 weeks ago

London, Greater London, United Kingdom CK Group Full time
Position Overview:
CK Group is seeking a Senior Associate or Manager specializing in Global Clinical Trial Transparency and Disclosure for a reputable global pharmaceutical organization. This role focuses on ensuring adherence to disclosure protocols that align with the company's Clinical Trial Transparency Policy and relevant regulations.

Key Responsibilities:
  • Oversee and coordinate all tasks necessary to fulfill disclosure requirements for clinical trial registration, maintenance, and results dissemination across applicable platforms.
  • Collaborate with both internal and external teams to ensure a comprehensive understanding of transparency and disclosure responsibilities.
  • Engage with vendors to guarantee that disclosure tasks are executed in accordance with established policies, procedures, and regulatory standards.
  • Stay informed about current and emerging guidelines related to disclosure processes, updating internal practices and providing training as necessary.
  • Act as a Subject Matter Expert (SME) in the implementation and enhancement of the disclosure system, from conception through to deployment.
  • Participate in the ongoing evaluation of disclosure activities for potential risks, ensuring that identified risks are documented, managed, and that mitigation strategies are developed.
  • Prepare and deliver training materials on the comprehensive disclosure operations process, significant process modifications, and other relevant topics to all stakeholders.
  • Contribute to the global awareness of clinical trial disclosure and its evolving requirements within the organization.

Candidate Profile:
To be considered for this position, candidates should possess:
  • A degree in life sciences or a related discipline.
  • In-depth knowledge of clinical disclosure regulations, including FDAAA801, EudraCT, and PhRMA/EFPIA data sharing principles.
  • Demonstrated expertise in clinical trial transparency or disclosure within the pharmaceutical sector.
  • Strong familiarity with study registration and results disclosure processes.
  • A solid understanding of clinical development in the pharmaceutical industry.
  • Exceptional communication and relationship management skills, with the ability to navigate projects with competing priorities in a matrixed team environment.

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