Madison,
NJ
07940
US
Posted: 11/16/2023
2023-11-16
2023-12-31
Job Number: 25671695
Pay Rate: 37.75-38.5 USD/Hour
Job Description
CLINICAL TRIALS DISCLOSURE SPECIALIST
MADISON, NJ
Role is 100% onsite.
CW can work from Madison, NJ or Lawrenceville, NJ.
The pay ranges between $37.75 - $38.50 per hour.
Project 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 processes and manage unmet needs.
- Trains new staff and develops job aids, work instructions, and user guides, as needed.
Required Skills:
- BA/BS or MA/MS in scientific or medical field.
- 2-3 years of document redaction and 5 years relevant work experience in a scientific or medical field with BA/BS.
- US military experience will be considered towards industry experience requirements.
- 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.
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01852
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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