Address
Form of workJob Description: Role is 100% onsite
CW can work from Madison, NJ or Lawrenceville, NJ
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
