Manager, Clinical Trial Disclosure

3 - 6 years

8 - 13 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

We are looking for a highly skilled and experienced professional with 2 to 7 years of experience to join our team as a Manager, Clinical Trial Disclosure in Mumbai.
Roles and Responsibility
  • Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations.
  • 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 data sharing and document redaction, as appropriate.
  • 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.
Job Requirements
  • Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies.
  • 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.
  • MA/MS in scientific or medical field.
  • 2-3 years of transparency experience and 5 years relevant work experience in a scientific or medical field with BA/BS.
About Company
Bristlecone is a leading healthcare company committed to transforming patients' lives through science. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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