Clinical Trials Disclosure Specialist

17 hours ago

Jersey City, New Jersey, United States Hays Recruitment Full time
Clinical Trials Disclosure Specialist Job Description

We are seeking a highly skilled Clinical Trials Disclosure Specialist to join our team at Hays Recruitment. As a Clinical Trials Disclosure Specialist, you will play a critical role in ensuring the accurate and timely disclosure of clinical trial information to regulatory authorities and other stakeholders.

Key Responsibilities:
  • Manage and coordinate the redaction of clinical trial documents in accordance with evolving 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 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.
  • Assist in monitoring the global regulatory environment and maintain a working knowledge of disclosure requirements.
  • Communicate with internal and external stakeholders to improve processes and manage unmet needs.
  • Train new staff and develop job aids, work instructions, and user guides, as needed.
Requirements:
  • BA/BS or MA/MS in a 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.
Benefits:

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K, and Life Insurance ($20,000 benefit).

We are committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law.

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