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Clinical Trials Disclosure Specialist

Summit, NJ 07901

Posted: 06/06/2023 Employment Type: Contract Job Number: 561361 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 30-38.56/hr **salary will be commensurate with experience 

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 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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