Clinical Records Management ManagerVirtualVocations • Jamaica, New York, United States
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Clinical Records Management Manager
VirtualVocations • Jamaica, New York, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
A company is looking for a Manager, Clinical Records Management.
Key Responsibilities
Conducts quality reviews of Trial Master Files for completeness and timeliness
Provides central records support across various stakeholders, including study teams and vendors
Drafts documents for clinical records management in compliance with GCP and regulations
Required Qualifications
Bachelor's or advanced degree in life sciences, pharmacy, or a related field
Minimum of 6-8 years of relevant experience in the biotech or pharmaceutical industry without a Master's, or 4-6 years with a Master's
Experience in clinical records management and understanding of GCP and regulatory guidelines
Familiarity with Trial Master File structure and TMF systems
Experience working with vendors and supporting regulatory inspections
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