CLINICAL - CLINICAL TRIALS DISCLOSURE SPECIALIST - Madison New Jersey

Company: Futran Tech Solutions Pvt. Ltd.
Location: Madison, New Jersey
Posted On: 11/17/2024

Job Description: 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
Additional Sills: More...

Register an account with us and set up job agents! We'll email you immediately when jobs like this are posted on our site.