Clinical - Clinical Trials Disclosure Specialist - Aequor Technologies LLC
Madison, NJ 07940
About the Job
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
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
Source : Aequor Technologies LLC
