Description:
Clinical Trial & Pharmacovigilance Manager
Location: Hybrid
Job Type: Full-Time
About the Role
We are seeking an experienced Clinical Trial & Pharmacovigilance Manager to oversee clinical studies and ensure robust safety surveillance.
Requirements:
Key Responsibilities
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Manage clinical trial operations from startup to closeout
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Oversee adverse event reporting and pharmacovigilance systems
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Ensure compliance with GCP and regulatory requirements
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Coordinate DSMB activities and safety reviews
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Develop and manage clinical study documentation
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Collaborate with regulatory teams on submissions
Qualifications
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Advanced degree in clinical research, life sciences, or healthcare field
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8+ years of clinical operations and safety experience
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Strong knowledge of ICH-GCP and FDA regulations
Preferred
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Experience with safety databases (Argus, ArisG)
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Clinical trial management certification
