Clinical Trials Disclosure Specialist - LanceSoft Inc
Madison, NJ 07940
About the Job
Role is 50% onsite
CW can work from Giralda Farms, NJ. or Lawrenceville, NJ.
Please be sure to list which site your candidate prefers on their resume and in the comments section. Local candidates are preferred.
EM wishes to see resumes before the end of this week. I will qualify candidates before the 3 day SLA.
Must Have List:
Key Responsibilities and Major Duties:
The Clinical Trial Disclosure Senior Specialist will provide the operational support of:
Candidate requirements:
CW can work from Giralda Farms, NJ. or Lawrenceville, NJ.
Please be sure to list which site your candidate prefers on their resume and in the comments section. Local candidates are preferred.
EM wishes to see resumes before the end of this week. 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
Key Responsibilities and Major Duties:
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.
- 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 : LanceSoft Inc
