Clinical Trial Manager

The Company
enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program detalimogene voraplasmidis being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive. Detalimogne voraplasmid 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. For more information, visit enGene.com.

Role

Clinical Trial Manager (CTM) will lead the day-to-day operations of assigned studies and ensures deliverables are met in terms of quality, compliance, and timelines. Strong management of and relationship with external vendors and CROs is critical for this role. The position will report to Clinical Project Management. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

Essential Duties And Responsibilities

• Perform day to day study execution activities and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
• Lead study feasibility assessment and site start up activities
• Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, etc.
• Work with key stakeholders to oversee the timely development and finalization of key study plans and manuals.
• Provide input and guidance on operational considerations to protocol development
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status and issues to ensure timely decision-making by senior management
  
  
  
  

Skills

• History of successfully developing effective relationships with outside vendors, CROs, and central/specialty labs
• Demonstrated experience with EDC, IRT and eTMF platforms
• Experience in developing training and/or informational material and presenting to both internal and external stakeholders
• Advanced skills in Project Management, particularly regarding management of schedule, budget, communication, resources, and quality
• Ability to analyze, evaluate and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation
  
  
  
  

Required Experience And Qualifications

• Bachelor’s degree required; Advanced degree preferred
• 5+years of experience in a clinical trial experience in the pharmaceutical or biotech industry
• Minimum of 4 years managing aspects of clinical trial activities (start-up through close-out), preferably in a global environment
• Oncology experience required.
• Solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  
  
  
  

enGene USA Inc. is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.