Clinical Trials Disclosure Specialist

2 weeks ago


Madison, New Jersey, United States Innova Solutions Full time
Job Title: Clinical Trials Disclosure Specialist

Innova Solutions is seeking a highly skilled Clinical Trials Disclosure Specialist to join our team. As a Clinical Trials Disclosure Specialist, you will play a critical role in ensuring compliance with evolving global regulations and providing operational support to our clients.

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, 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.
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.
About Innova Solutions:

Innova Solutions is a global leader in providing strategic technology and business transformation solutions to our clients. We are committed to delivering high-quality services and fostering a culture of innovation and excellence.

We are an equal opportunity employer and prohibit any kind of unlawful discrimination and harassment. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or Please indicate the specifics of the assistance needed.



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