Job Description

Job Title: Clinical Trials Disclosure Specialist

Job ID: (phone number removed)

Location: Madison, NJ, 07940

Duration: 12 Months contract on W2

Role is 50% onsite

CW can work from Giralda Farms, 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 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

Contact

Satya S | Direct: (phone number removed) | Email: | URL: (url removed)

Job Tags

Permanent employment, Contract work, Work experience placement,

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