Senior Manager

3 weeks ago


South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

Clinical Trial Transparency & Disclosure Lead

**Job Summary**

Katalyst Healthcares & Life Sciences is seeking a highly experienced Clinical Trial Transparency & Disclosure Lead to join our team. As a key member of our Clinical Management team, you will be responsible for providing guidance on overall Clinical Trial processes and conduct, ensuring compliance with transparency regulations.

**Key Responsibilities**

* Provide expert guidance on Clinical Trial processes and conduct to the Transparency team
* Perform clinical trial registration and/or results disclosure activities as necessary
* Assess the process between the Clinical Management team and the CTT&D team, recommending improvements
* Collaborate with the system implementation team to conduct User Acceptance Testing (UAT) on transparency platforms
* 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

**What We Offer**

* Opportunity to work with a leading healthcare company
* Collaborative and dynamic work environment
* Competitive salary and benefits package

**How to Apply**

If you are a motivated and experienced professional looking to take your career to the next level, please submit your application, including your resume and a cover letter, to [insert contact information].


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