What are the responsibilities and job description for the Senior Clinical Trials Manager - Katalyst Healthcares & Life Sciences position at Katalyst Healthcares & Life Sciences?
Role Overview:
Katalyst Healthcares & Life Sciences is a leading healthcare company that provides innovative solutions to improve patient outcomes. We are currently seeking a highly skilled Senior Clinical Trials Manager to join our team.
As a Senior Clinical Trials Manager, you will play a critical role in ensuring the success of our clinical trials by providing guidance to the transparency team and conducting required registration and disclosure activities. You will also work closely with the Clinical Management team and the CTT&D team to assess the process and recommend improvements. Additionally, you will collaborate with the system implementation team to ensure the functionality of transparency platforms like Prime.
Key Responsibilities:
Requirements:
Katalyst Healthcares & Life Sciences is a leading healthcare company that provides innovative solutions to improve patient outcomes. We are currently seeking a highly skilled Senior Clinical Trials Manager to join our team.
As a Senior Clinical Trials Manager, you will play a critical role in ensuring the success of our clinical trials by providing guidance to the transparency team and conducting required registration and disclosure activities. You will also work closely with the Clinical Management team and the CTT&D team to assess the process and recommend improvements. Additionally, you will collaborate with the system implementation team to ensure the functionality of transparency platforms like Prime.
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.
