Clinical Trials Disclosure Specialist

3 hours ago

Cedarville, New Jersey, United States Net2source Full time
Job Title: Clinical Trials Disclosure Specialist

Net2Source Inc. is a leading provider of total workforce solutions, recognized for our accelerated growth and global operations. We believe in delivering staffing solutions to address the talent gap and acting as a career coach to our consultants.

Job Summary:

The Clinical Trials Disclosure 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 operationalize redaction requirements, provide vendor oversight, and work with IT to implement technology solutions.

Key Responsibilities:

  • Manage and coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
  • Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.
  • Provide vendor oversight to support document redactions.
  • Work with IT, as needed, to implement technology solutions related to clinical trial disclosure.
  • Manage and track redaction book-of-work; 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 maintains working knowledge of disclosure requirements.
  • Communicate with internal and external stakeholders to improve on processes and manage unmet need.
  • Train new staff and develops job aids, work instructions, and user guides, as needed.

Candidate Requirements:

  • BA/BS or MA/MS in scientific or medical field.
  • 2-3 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 (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.).
  • 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.

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