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Form of workJob Description
Job Title: Clinical Trials Disclosure Specialist
Location: SUMMIT, NJ, 07901 (can work from Summit West, NJ or Lawrenceville, NJ)
Duration: 12 Months
Role is 50% onsite (Hybrid)
CW can work from Summit West, NJ or Lawrenceville, NJ
Position Summary:
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.
Job 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.
