Clinical Trials Disclosure Specialist in Madison, NJ

Role is 50% onsite

CW can work from Giralda Farms, NJ. or Lawrenceville, NJ

Candidate must be able to work 50% onsite at either Giralda Farms or Lawrenceville, NJ.

Local candidates are preferred.

I will qualify candidates before the 3 day SLA.

Must Have List:

• 2+ years in the Biopharma space
• 2+ years of Project Management experience
• 1+ years of medical/scientific writing experience
• 2+ years of document redaction/Clinical Trial transparency experience
• QC experience

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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