Senior Manager
Katalyst HealthCares & Life Sciences
Job Title
Essential Duties and 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
Vacancy posted 3 days ago
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