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
