What are the responsibilities and job description for the Clinical Management Specialist position at Katalyst Healthcares & Life Sciences?
Job Description:
Katalyst Healthcares & Life Sciences is a dynamic and growing healthcare company that offers exciting opportunities for professional growth and development. As a Senior Clinical Trials Manager, you will have the opportunity to contribute to the success of our clinical trials by providing guidance to the transparency team and conducting required registration and disclosure activities.
Key Responsibilities:
Requirements:
Katalyst Healthcares & Life Sciences is a dynamic and growing healthcare company that offers exciting opportunities for professional growth and development. As a Senior Clinical Trials Manager, you will have the opportunity to contribute to the success of our clinical trials by providing guidance to the transparency team and conducting required registration and disclosure activities.
Key Responsibilities:
- Provide guidance to the transparency team on overall clinical trial processes and conduct required registration and disclosure activities.
- Assess the overall process between the Clinical Management team and the CTT&D team and recommend improvements.
- Collaborate with the system implementation team to ensure the functionality of transparency platforms like Prime.
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.
