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Senior Clinical Project Manager
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- enGene is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG).
- EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company.
- As an integral member of the team, the Senior Clinical Project Manager will report to the VP of Clinical Development Operations and work closely with cross functional team members, clinical research organizations (CROs), and other vendors to ensure clinical trial execution is conducted in accordance with the protocol, SOPs, ICH/GCP/regulatory guidelines, and company goals while ensuring quality of study execution and timely delivery of trial milestones.
- Ensure oversight of the TMF appropriately throughout the trial, including periodic reviews
- Participates in UAT for EDC/IRT
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