Clinical Trials Disclosure Specialist

13 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 in 32 countries. We offer staffing solutions to address the talent gap and act 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 requires collaboration with key business partners, including Clinical Development Leads, Global Development Operations, and Medical Writing teams.

Key Responsibilities:

  • Manage and coordinate the 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, and Submission Managers 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 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 maintain working knowledge of disclosure requirements.
  • Communicate with internal and external stakeholders to improve processes and manage unmet needs.
  • 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.
  • 2-3 years of document redaction experience and 3+ years of relevant work experience in a scientific or medical field with a 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.

Location: Madison, NJ 07940 or Lawrenceville, NJ 08648 (50% onsite)

Duration: 12 months contract (possible extension)

Pay Rate: $37.75/hr on W2

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