Clinical Trials Disclosure Specialist

**W2 candidates within 40 miles radius of the location as it is a hybrid role**

Title: Clinical Trials Disclosure Specialist

Duration: 12 months +

Location: Summit, NJ Hybrid (50% Onsite)

Project Description:

• 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.
• 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 processes and manage unmet needs.
• Trains new staff and develops job aids, work instructions, and user guides, as needed.

Required Skills:

• 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.

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

ALPHA'S REQUIREMENT #23-00779