Our client, a leading pharmaceutical company, is hiring a Clinical Trials Disclosure Specialist, on a contract basis.
Job ID #: 80606
Work Location:
Lawrenceville, NJ – 50% on site
Education/Experience:
- BA/BS or MA/MS in scientific or medical field
- 2 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
- 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
Responsibilities:
- 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