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Clinical Trials Disclosure Specialist

Summit, NJ 07901

Posted: 06/06/2023 Employment Type: Contract Job Number: 561361 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 30-38.56/hr **salary will be commensurate with experience 

Position Summary:

The Clinical Trial Disclosure Senior Specialist will provide the operational support of Redaction of clinical trial documents in accordance with evolving global regulations.
Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers.

Key Responsibilities and Major Duties:
  • 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
  • Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
  • Communicates with internal and external stakeholders to improve on processes and manage unmet need
  • Trains 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 5 years relevant work experience in a scientific or medical field with BA/BS
  • US military experience will be considered towards industry experience requirements
  • 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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