Job Title : Clinical Trials Disclosure Specialist
Job ID : -
Location : Madison, NJ,
Duration : Months contract on W
Role is % 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 , 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
- years of document redaction and + 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
Clinical Trials Disclosure Specialist
Clinical Trials Disclosure Specialist. ...
Clinical Trials Disclosure Specialist
Clinical Trials Disclosure Specialist. A Leading pharmaceutical company, with locations in NJ is looking to bring on a Clinical Trials. ...
Clinical - Clinical Trials Disclosure Specialist
The Clinical Trial Disclosure Senior Specialist will provide the operational support of: Redaction of clinical trial documents in accordance with evolving global regulations. Manage and Coordinate redaction of clinical documents in accordance with EMA Policy , Health Canada Public Release of Clinica...
Clinical Trials Disclosure Specialist
Job Title: Clinical Trials Disclosure Specialist. The Clinical Trial Disclosure Senior Specialist will provide the operational support of:. Manage and Coordinate redaction of clinical documents in accordance with EMA Policy , Health Canada Public Release of Clinical Information (PRCI), EU Clinical T...
Clinical - Clinical Trials Disclosure Specialist
The Clinical Trial Disclosure Senior Specialist will provide the operational support of:. Manage and Coordinate redaction of clinical documents in accordance with EMA Policy , Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations. Wor...
Clinical - Clinical Trials Disclosure Specialist
The Clinical Trial Disclosure Senior Specialist will provide the operational support of:. Manage and Coordinate redaction of clinical documents in accordance with EMA Policy , Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations. Wor...
Hiring: Clinical Trials Disclosure Specialist || Madison, NJ
Job Title: Clinical Trials Disclosure Specialist. The Clinical Trial Disclosure Senior Specialist will provide the operational support of:. Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinic...
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Job Name: Clinical Trials Disclosure Specialist Location: Giralda Farms, NJ or Lawrenceville, NJ Contractor Work Model: Role is 50% onsite A Leading pharmaceutical company, with locations in NJ is looking to bring on a Clinical Trials Disclosure Specialist to join their team. Collaborate with Glob...
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Clinical Trials Disclosure Specialist. A Leading pharmaceutical company, with locations in NJ is looking to bring on a Clinical Trials Disclosure Specialist to join their team. The Clinical Trial Disclosure Senior Specialist will provide the operational support of:. Manage and Coordinate redaction o...
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