Clinical Trials Disclosure Specialist
4 weeks ago
Sunrise Systems, Inc. is seeking a highly skilled Clinical Trial Disclosure Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for providing operational support for the redaction of clinical trial documents in accordance with evolving global regulations.
Key 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.
- Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements.
- Communicate with internal and external stakeholders to improve on processes and manage unmet need.
- Train 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 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.
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