Senior Manager
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Responsibilities:
Provide guidance to the Transparency team on overall Clinical Trial processes and conduct.
Perform required clinical trial registration and/or results disclosure activities as necessary.
Assess the overall process between the Clinical Management team and the CTT&D team, recommending improvements.
Collaborate with the system implementation team, conduct User Acceptance Testing (UAT) on transparency platforms like Prime, ensuring functionality and suggesting enhancements.
Develop training materials for the CTT&D team on platform usage.
Required Competencies:Minimum 5 years of experience in the pharmaceutical/biotech industry.
Hands-on experience in Clinical Trial management.
Comprehensive knowledge of transparency regulations, including FDAAA 801, EU CTR 536/2014, and Health Canada (HC) Public Release of Clinical Information (PRCI).
Familiarity with automated platforms for Clinical Trial Transparency.
Experience in vendor management and working with multiple CROs on behalf of the sponsor
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