What are the responsibilities and job description for the Clinical Trial Process Expert position at Katalyst Healthcares & Life Sciences?
Job Summary:
Katalyst Healthcares & Life Sciences seeks a seasoned Clinical Trials Manager to oversee the transparency team's activities. The ideal candidate will possess extensive knowledge of clinical trial processes, transparency regulations, and experience working with automated platforms.
The successful candidate will provide guidance to the transparency team on overall clinical trial processes and conduct required registration and disclosure activities. They will assess the process between the Clinical Management team and the CTT&D team, recommending improvements, and collaborate with the system implementation team to ensure functionality and suggest enhancements.
Key Responsibilities:
Requirements:
Katalyst Healthcares & Life Sciences seeks a seasoned Clinical Trials Manager to oversee the transparency team's activities. The ideal candidate will possess extensive knowledge of clinical trial processes, transparency regulations, and experience working with automated platforms.
The successful candidate will provide guidance to the transparency team on overall clinical trial processes and conduct required registration and disclosure activities. They will assess the process between the Clinical Management team and the CTT&D team, recommending improvements, and collaborate with the system implementation team to ensure functionality and suggest enhancements.
Key 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.
Requirements:
- 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.
