Clinical Trials Disclosure Specialist

4 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 be responsible for providing operational support for the redaction of clinical trial documents in accordance with evolving global regulations.

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 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 develop job aids, work instructions, and user guides, as needed.

Requirements:

  • BA/BS or MA/MS in a 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 technology and business transformation solutions. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.



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