Clinical Trial Manager

Job Responsibilities :

• Manage assigned clinical studies within a designated budget and timeline.
• Conduct CRO, Vendor and site assessment and selection; negotiating budget and contracts.
• Conduct site qualification, initiation, interim monitoring and close-out visits. Collecting and reviewing trial master documentation. Document results of visits in monitoring reports for review and finalization.
• Facilitate IRB submissions and renewals when needed.
• Oversee clinical sites, central lab, and other third parties to ensure issues are resolved timely. Motivating investigational sites to close queries and action items.
• Develop or review clinical project plans and clinical trial documentation.
• Collaborate with Regulatory to prepare FDA pre-submission and submission packages.
• Oversee the development of a clinical study database by third party, review and summarize clinical data, perform data analysis and reports.
• Oversee all study team members training to ensure accurate execution of clinical protocols.

Qualifications :