Senior Manager (South Plainfield)

Essential Duties and 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.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