Clinical Trials Disclosure Specialist - Primary Talent Partners
Madison, NJ 07940
About the Job
Primary Talent Partners has a 12-month contract opening for a Clinical Trials Disclosure Specialist with a pharmaceutical client of ours. You can work out of Madison, NJ or Lawrenceville, NJ.
Duration: 12-month W2 contract, no PTO or benefits included
Pay: $33 - $37.75
Location: Giralda Farms, NJ, or Lawrenceville, NJ - Role is 50% onsite
Job Description:
The Clinical Trial Disclosure Senior Specialist will provide the operational support of:
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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Duration: 12-month W2 contract, no PTO or benefits included
Pay: $33 - $37.75
Location: Giralda Farms, NJ, or Lawrenceville, NJ - Role is 50% onsite
Job Description:
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
- 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
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP
Source : Primary Talent Partners