Clinical Trials Disclosure Specialist

1 month ago

Cedarville, New Jersey, United States Axelon Full time
Job Summary:

The Clinical Trial Disclosure Senior Specialist will provide operational support for the redaction of clinical trial documents in accordance with evolving global regulations. This role will collaborate with key business partners to ensure compliance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.

Key Responsibilities:

  • Manage and coordinate redaction of clinical documents in accordance with global regulations.
  • Collaborate with stakeholders to operationalize redaction requirements.
  • Provide vendor oversight to support document redactions.
  • Work with IT to implement technology solutions related to clinical trial disclosure.
  • Manage and track redaction bookofwork; compile and report on volume and performance metrics.
  • Provide operational support to CT Results Specialists, as required.
  • Assist in monitoring the global regulatory environment and maintain working knowledge of disclosure requirements.
  • Communicate with internal and external stakeholders to improve processes and manage unmet need.
  • Train new staff and develop job aids, work instructions, and user guides, as needed.

Candidate Requirements:

  • BA/BS or MA/MS in a scientific or medical field.
  • 23 years of document redaction and 3+ years relevant work experience in a scientific or medical field with BA/BS.
  • Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies.
  • Familiarity and comfortability working with and discussing scientific data.
  • Project and stakeholder management experience.
  • Demonstrated ability to work independently and seek out support when needed.
  • Exceptional written and oral communication skills.
  • Strong organizational skills with the ability to multitask and prioritize.