Clinical - Clinical Trials Disclosure Specialist Job Madison area,New Jersey USA,Healthcare

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 red actions.

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 maintain working knowledge of disclosure requirements.

Communicate with internal and external stakeholders to improve on processes and manage unmet need.

Train new staff and develop 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.

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