What are the responsibilities and job description for the Transparency Team Lead - Pharmaceutical Industry position at Katalyst Healthcares & Life Sciences?
About the Role:
We are seeking an experienced Senior Clinical Trials Manager to join our team at Katalyst Healthcares & Life Sciences. This is an excellent opportunity for someone who wants to make a meaningful contribution to the success of our organization.
As a Senior Clinical Trials Manager, you will be responsible for providing guidance to the transparency team on overall clinical trial processes and conducting required registration and disclosure activities. You will 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.
Your Key Responsibilities Will Include:
What We're Looking For:
We are seeking an experienced Senior Clinical Trials Manager to join our team at Katalyst Healthcares & Life Sciences. This is an excellent opportunity for someone who wants to make a meaningful contribution to the success of our organization.
As a Senior Clinical Trials Manager, you will be responsible for providing guidance to the transparency team on overall clinical trial processes and conducting required registration and disclosure activities. You will 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.
Your Key Responsibilities Will Include:
- Providing guidance to the transparency team on overall clinical trial processes and conducting required registration and disclosure activities.
- Assessing the overall process between the Clinical Management team and the CTT&D team and recommending improvements.
- Collaborating with the system implementation team to ensure the functionality of transparency platforms like Prime.
What We're Looking For:
- At least 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.
