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Jobs or company...

Clinical Trial Documentation Specialist

  • Full Time, onsite
  • Integrated Resources, Inc ( IRI )
  • Princeton, United States of America
Salary undisclosed

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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 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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